UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
Report
- Report Number
- 8030965-2019-64944
- Event Type
- Injury
- Date Received
- June 5, 2019
- Date of Event
- May 15, 2019
- Report Date
- February 16, 2019
- Manufacturer
- DAI
- Product Code
- JDS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10: ADDITIONAL NARRATIVE: B5, B7, D1. H11: CORRECTED DATA: G4: INITIAL AWARENESS DATE REPORTED AS FEBRUARY 16, 2019; HOWEVER, IT SHOULD HAVE BEEN (B)(6) 2019. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. B3: ADDED PROCEDURE DATE: (B)(6) 2019. E3: SYNTHES EMPLOYEE SENIOR CLINICAL RESEARCH ASSOCIATE ADDED IN ASSOCIATED CONTACTS: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: B5 B7 DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
ADDITION ADVERSE EVENTS REPORTED: THE PATIENT UNDERWENT AN INTERNAL FIXATION OF FEMORAL INTERTROCHANTERIC FRACTURE ON (B)(6) 2019, POSTOPERATIVELY, THE PATIENT HAD BLOODSTREAM INFECTIONS ON AN UNKNOWN DATE AND IS ONGOING, WITH IMPROVEMENT. THE PATIENT WAS GIVEN ANTI-INFECTION AND ANTICOAGULANT MEDICATIONS UTILIZING TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM. REPORTEDLY, THE PATIENT EXPERIENCED MODERATE INCISION PAIN ON (B)(6) 2019. THE PATIENT WAS GIVEN A MEDICATION FOR INCISION PAIN. ON (B)(6) 2019, THE PATIENT HAD LOW BLOOD PRESSURE, INCISION EFFUSION AND INCISION SWELLING. THE REPORTED ADVERSE EVENT FOR LOW BLOOD PRESSURE WAS RESOLVED WITHOUT SEQUELA ON THE SAME DAY WHILE INCISION EFFUSION AND INCISION SWELLING WAS ON (B)(6) 2019. INCISION PAIN WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. THE PATIENT HAD A MILD ANEMIA ON AN UNKNOWN DATE AND IS ONGOING, UNCHANGED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DELIRIUM AND WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT PRESENTED THYROID NODULE AND IS ONGOING, UNCHANGED; ALSO DEVELOPED SKIN INFECTION. EVENTUALLY, THE PATIENT DID NOT HAVE FEVER, COUGH OR EXPECTORATION, CHEST TIGHTNESS OR CHEST PAIN, OR OTHER DISCOMFORTS. THE PATIENT HAD A SEVERE PLEURAL EFFUSION ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT PRESENTED URINARY TRACT INFECTION AND THE REPORTED ADVERSE EVENT WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. THE REPORTED ADVERSE EVENT FOR SKIN INFECTION AND PLEURAL EFFUSION WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. THE PATIENT WAS ADMITTED ON AN UNKNOWN DATE AND DURING THE HOSPITAL STAY, THE PATIENT WAS GIVEN STOMACH PROTECTION, ANTI-INFECTION, CHEST DRAINAGE AND OTHER TREATMENTS. AT DISCHARGE, THE PATIENT DID NOT HAVE FEVER, COUGH OR EXPECTORATION, CHEST TIGHTNESS OR PAIN, OR OTHER DISCOMFORTS. THE PATIENT¿S CONDITION WAS STABLE AND WAS DISCHARGED ON (B)(6) 2019. THE PATIENT WAS INSTRUCTED TO VISIT THE LOCAL HOSPITAL FOR MEROPENEM INJECTION 0.5 INTRAVENOUS DRIP, ONCE DAILY FOR 5 DAYS AND FOLLOW UP LEFT PLEURAL FLUID AND WILL RECEIVE CATHETERIZATION AND DRAINAGE IF THERE IS A GREAT AMOUNT OF PLEURAL FLUID. ON (B)(6) 2019, THE INVESTIGATOR CALLED THE PATIENT BY PHONE AND FOUND THAT THE PATIENT WAS STILL EXPERIENCING HYPERPYREXIA REPEATEDLY AND STAYED IN THE LOCAL HOSPITAL FOR CONTINUED ANTI-INFECTION THERAPY WITH MEROPENEM INJECTION.
UPDATE: 6/1/2020: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT ACCIDENTALLY FELL AT HOME WITHOUT PASSING OUT. THE PATIENT IMMEDIATELY FELT PAIN OVER THE RIGHT HIP AND COULD NOT GET UP, BUT DID NOT HAVE HEADACHE, DIZZINESS OR DEFORMITY OF THE LIMBS. THE PATIENT WAS SENT TO A LOCAL HOSPITAL WHERE AN X-RAY WAS TAKEN WHICH SUGGESTED A RIGHT INTERTROCHANTERIC FRACTURE AND WAS GIVEN SYMPTOMATIC TREATMENT. ON (B)(6) 2019, THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT OF THE HOSPITAL. A PHYSICAL EXAMINATION (PE) WAS PERFORMED AND ANOTHER X-RAY WAS TAKEN AND RESULTED THE SAME. THE PATIENT¿S CONDITION DID NOT CHANGE WHILE WAITING FOR ADMISSION. ON (B)(6) 2019, AN INFORMED CONSENT FORM FOR ¿A PROSPECTIVE STUDY ON THE EVALUATION OF METAL INTRAMEDULLARY NAIL SYSTEM IN CHINESE PATIENTS¿ WAS SIGNED. THE PATIENT¿S EXAMINATION RESULTS MET THE INCLUSION CRITERIA AND DID NOT MEET ANY OF THE EXCLUSION CRITERIA. IT WAS RANDOMIZED AT 10:19 AM AND ALLOCATED TO THE TEST GROUP (TFNA), WITH A RANDOM NUMBER OF 194. THE PATIENT UNDERWENT AN INTERNAL FIXATION OF FEMORAL INTERTROCHANTERIC FRACTURE ON (B)(6) 2019, POSTOPERATIVELY, THE PATIENT EXPERIENCED FEVER ON AN UNKNOWN DATE OF (B)(6) 2019. THE REPORTED ADVERSE EVENT WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. THE PATIENT WAS GIVEN ANTI-INFECTION AND ANTICOAGULANT MEDICATIONS UTILIZING TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM. REPORTEDLY, THE PATIENT EXPERIENCED MODERATE INCISION PAIN ON (B)(6) 2019. THE PATIENT WAS GIVEN A MEDICATION FOR INCISION PAIN. ON (B)(6) 2019, THE PATIENT HAD LOW BLOOD PRESSURE, INCISION EFFUSION AND INCISION SWELLING. THE REPORTED ADVERSE EVENT FOR LOW BLOOD PRESSURE WAS RESOLVED WITHOUT SEQUELA ON THE SAME DAY WHILE INCISION EFFUSION AND INCISION SWELLING WAS ON (B)(6) 2019. INCISION PAIN WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. THE PATIENT¿S CONDITION WAS GOOD AND WAS DISCHARGED WITH MEDICATIONS ON FEBRUARY 18. HOWEVER, AFTER BEING DISCHARGED, THE PATIENT DEVELOPED FEVER SYMPTOMS WITHOUT A NOTICEABLE INCENTIVE AND GOT ADMITTED WITH A BODY TEMPERATURE THAT RANGED UP TO 38¿C ON AN UNKNOWN DATE. THE PATIENT DID NOT HAVE CHILLS, SHIVER, COUGH OR EXPECTORATION, CHEST TIGHTNESS OR BREATHLESSNESS, ABDOMINAL PAIN OR DIARRHEA, FREQUENT URGENT OR PAINFUL MICTURITION, OR SYSTEMIC MUSCLE SORENESS. AN ANTI-INFECTIVE TREATMENT WAS ADMINISTERED, AND THE BODY TEMPERATURE RETURNED TO NORMAL AND THE PATIENT GOT DISCHARGED ON AN UNKNOWN DATE. A WEEK AFTER BEING DISCHARGED, THE PATIENT DEVELOPED FEVER AGAIN WITH A BODY TEMPERATURE UP TO 40¿C AND WAS ADMITTED. A ROUTINE BLOOD TEST SHOWED: WHITE BLOOD CELL (WBC) 5.5*10.9/L, CRP 147MG/L, ESR 86MG/L. CEFTRIAXONE 2G INTRAVENOUS DRIP INFUSION WAS GIVEN FOR ANTI-INFECTION, AND THE BODY TEMPERATURE IMPROVED, AND THE PATIENT WAS DISCHARGED. TWO WEEKS AFTER DISCHARGE, THE PATIENT DEVELOPED FEVER AGAIN WITH THE BODY TEMPERATURE UP TO 39¿C AND GOT ADMITTED WERE A ROUTINE BLOOD TEST SHOWED: WBC 6.6*10.9/L, CRP 76.4MG/L, ESR 47MG/L AND WAS GIVEN PIPERCILLIN AND TAZOBACTAM 4.5G INTRAVENOUS DRIP INFUSION FOR ANTI-INFECTION. THE BODY TEMPERATURE IMPROVED, AND THE PATIENT WAS DISCHARGED. THE PATIENT HAD A MILD ANEMIA ON AN (B)(6) 2019. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DELIRIUM AND WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. THE PATIENT DEVELOPED FEVER AGAIN ON MAY 12, WITH A BODY TEMPERATURE UP TO 38¿C. FOR FURTHER DIAGNOSIS AND TREATMENT, THE PATIENT WAS ADMITTED TO THE INFECTIOUS DISEASE DEPARTMENT WITH A DIAGNOSIS OF RECURRENT FEVER FOR OVER TWO MONTHS. AFTER ADMISSION, A ROUTINE BLOOD TEST SHOWED: WBC 6.5*10.9/L, HEMOGLOBIN 91G/L, NEUTROPHIL PERCENTAGE 65.7%, PLATELET COUNT 183*10^9/L, C-REACTIVE PROTEIN 64.3MG/L, ALBUMIN 27.7G/L. COMPUTED TOMOGRAPHY (CT) SCAN OF THE CHEST, RIGHT FEMUR, AND WHOLE ABDOMEN SUGGESTED DORSAL HYPOSTATIC CHANGES AT BILATERAL LOWER LOBES WITH A SMALL AMOUNT OF PLEURAL EFFUSION ON BOTH SIDES. THE PATIENT WAS GIVEN MEROPENEM, PIPERCILLIN AND TAZOBACTAM, AND VANCOMYCIN SUCCESSIVELY AS ANTI-INFECTIVE TREATMENT, MASSIVE FLUID REPLACEMENT, AND ASYMPTOMATIC AND SUPPORTIVE TREATMENTS SUCH AS STOMACH PROTECTION AND IRON SUPPLEMENT. THE PATIENT¿S HIGHEST BODY TEMPERATURE WAS 40°C. ON (B)(6) 2019, THE PATIENT EXPERIENCED MODERATE HYPOVOLEMIC SHOCK. ON (B)(6) 2019, THE PATIENT PRESENTED THYROID NODULE; ALSO DEVELOPED SKIN INFECTION. EVENTUALLY, THE PATIENT DID NOT HAVE FEVER, COUGH OR EXPECTORATION, CHEST TIGHTNESS OR CHEST PAIN, OR OTHER DISCOMFORTS. DURING THE WINDOW PERIOD OF VISIT 4, THE INVESTIGATOR CALLED THE PATIENT MULTIPLE TIMES FOR FOLLOW-UP AND ALL FAILED TO REACH THE PATIENT. AFTER THE WINDOW PERIOD, THE INVESTIGATOR REACHED THE PATIENT¿S FAMILY ONCE BY PHONE, BUT THE PATIENT¿S FAMILY REFUSED TO VISIT THE HOSPITAL, ASKED IF X-RAY FILMS FROM ANOTHER HOSPITAL CAN BE USED FOR DIAGNOSIS AND GOT AN ANSWER OF NO, THEREFORE, THIS PATIENT WAS LOST OF FOLLOW-UP FOR VISIT 4. DURING THE WINDOW PERIOD OF VISIT 5, THE INVESTIGATOR ALSO CALLED THE PATIENT MULTIPLE TIMES FOR FOLLOW-UP AND AGAIN FAILED TO REACH THE PATIENT. THE REPORTED ADVERSE EVENT FOR MODERATE HYPOVOLEMIC SHOCK WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. THIS AE WAS FOUND DURING THE TELEPHONE FOLLOW-UP ON (B)(6) 2019. THE PATIENT HAD A SEVERE PLEURAL EFFUSION ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT PRESENTED URINARY TRACT INFECTION AND MILD PAIN FROM THORACENTESIS. THE REPORTED ADVERSE EVENT WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019 AND THE REPORTED ADVERSE EVENT FOR URINARY TRACT INFECTION WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. THE REPORTED ADVERSE EVENT FOR SKIN INFECTION AND PLEURAL EFFUSION WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. THE PATIENT WAS ADMITTED ON AN UNKNOWN DATE AND DURING THE HOSPITAL STAY, THE PATIENT WAS GIVEN STOMACH PROTECTION, ANTI-INFECTION, CHEST DRAINAGE AND OTHER TREATMENTS. AT DISCHARGE, THE PATIENT DID NOT HAVE FEVER, COUGH OR EXPECTORATION, CHEST TIGHTNESS OR PAIN, OR OTHER DISCOMFORTS. THE PATIENT¿S CONDITION WAS STABLE AND WAS DISCHARGED ON (B)(6) 2019. THE PATIENT WAS INSTRUCTED TO VISIT THE LOCAL HOSPITAL FOR MEROPENEM INJECTION 0.5 INTRAVENOUS DRIP, ONCE DAILY FOR 5 DAYS AND FOLLOW UP LEFT PLEURAL FLUID AND WILL RECEIVE CATHETERIZATION AND DRAINAGE IF THERE IS A GREAT AMOUNT OF PLEURAL FLUID. ON (B)(6) 2019, THE INVESTIGATOR CALLED THE PATIENT BY PHONE AND FOUND THAT THE PATIENT WAS STILL EXPERIENCING HYPERPYREXIA REPEATEDLY AND STAYED IN THE LOCAL HOSPITAL FOR CONTINUED ANTI-INFECTION THERAPY WITH MEROPENEM INJECTION. A FOLLOW-UP REPORT IS HEREBY SUBMITTED, AND FURTHER FOLLOW-UP IS STILL REQUIRED. THE REPORTED ADVERSE EVENT FOR MILD ANEMIA AND MILD THYROID NODULE WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. CONCOMITANT PRODUCTS FIELD. UNK - NAILS: TFNA, UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE, UNK - SCREWS: LOCKING. THIS COMPLAINT INVOLVES THREE (3) DEVICES.
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT ACCIDENTALLY FELL AT HOME WITHOUT PASSING OUT. THE PATIENT IMMEDIATELY FELT PAIN OVER THE RIGHT HIP AND COULD NOT GET UP, BUT DID NOT HAVE HEADACHE, DIZZINESS OR DEFORMITY OF THE LIMBS. THE PATIENT WAS SENT TO A LOCAL HOSPITAL WHERE AN X-RAY WAS TAKEN WHICH SUGGESTED A RIGHT INTERTROCHANTERIC FRACTURE AND WAS GIVEN SYMPTOMATIC TREATMENT. ON (B)(6) 2019, THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT OF THE HOSPITAL. A PHYSICAL EXAMINATION (PE) WAS PERFORMED AND ANOTHER X-RAY WAS TAKEN AND RESULTED THE SAME. THE PATIENT¿S CONDITION DID NOT CHANGE WHILE WAITING FOR ADMISSION. ON (B)(6) 2019, AN INFORMED CONSENT FORM FOR ¿A PROSPECTIVE STUDY ON THE EVALUATION OF METAL INTRAMEDULLARY NAIL SYSTEM IN CHINESE PATIENTS¿ WAS SIGNED. THE PATIENT¿S EXAMINATION RESULTS MET THE INCLUSION CRITERIA AND DID NOT MEET ANY OF THE EXCLUSION CRITERIA. IT WAS RANDOMIZED AND ALLOCATED TO THE TEST GROUP (TFNA), WITH A RANDOM NUMBER OF 194. THE PATIENT UNDERWENT AN INTERNAL FIXATION OF FEMORAL INTERTROCHANTERIC FRACTURE. ON (B)(6) 2019, POSTOPERATIVELY, THE PATIENT EXPERIENCED FEVER ON AN UNKNOWN DATE OF (B)(6) 2019. THE REPORTED ADVERSE EVENT WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. THE PATIENT WAS GIVEN ANTI-INFECTION AND ANTICOAGULANT MEDICATIONS UTILIZING TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM. REPORTEDLY, THE PATIENT EXPERIENCED MODERATE INCISION PAIN ON (B)(6) 2019. THE PATIENT WAS GIVEN A MEDICATION FOR INCISION PAIN. ON (B)(6) 2019, THE PATIENT HAD LOW BLOOD PRESSURE, INCISION EFFUSION AND INCISION SWELLING. THE REPORTED ADVERSE EVENT FOR LOW BLOOD PRESSURE WAS RESOLVED WITHOUT SEQUELA ON THE SAME DAY WHILE INCISION EFFUSION AND INCISION SWELLING WAS ON (B)(6) 2019. INCISION PAIN WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. THE PATIENT¿S CONDITION WAS GOOD AND WAS DISCHARGED WITH MEDICATIONS ON (B)(6). HOWEVER, AFTER BEING DISCHARGED, THE PATIENT DEVELOPED FEVER SYMPTOMS WITHOUT A NOTICEABLE INCENTIVE AND GOT ADMITTED WITH A BODY TEMPERATURE THAT RANGED UP TO 38C ON AN UNKNOWN DATE. THE PATIENT DID NOT HAVE CHILLS, SHIVER, COUGH OR EXPECTORATION, CHEST TIGHTNESS OR BREATHLESSNESS, ABDOMINAL PAIN OR DIARRHEA, FREQUENT URGENT OR PAINFUL MICTURITION, OR SYSTEMIC MUSCLE SORENESS. AN ANTI-INFECTIVE TREATMENT WAS ADMINISTERED, AND THE BODY TEMPERATURE RETURNED TO NORMAL AND THE PATIENT GOT DISCHARGED ON AN UNKNOWN DATE. A WEEK AFTER BEING DISCHARGED, THE PATIENT DEVELOPED FEVER AGAIN WITH A BODY TEMPERATURE UP TO 40C AND WAS ADMITTED. A ROUTINE BLOOD TEST SHOWED: WHITE BLOOD CELL (WBC) 5.5*10.9/L, CRP 147MG/L, ESR 86MG/L. CEFTRIAXONE 2G INTRAVENOUS DRIP INFUSION WAS GIVEN FOR ANTI-INFECTION, AND THE BODY TEMPERATURE IMPROVED, AND THE PATIENT WAS DISCHARGED. TWO WEEKS AFTER DISCHARGE, THE PATIENT DEVELOPED FEVER AGAIN WITH THE BODY TEMPERATURE UP TO 39C AND GOT ADMITTED WERE A ROUTINE BLOOD TEST SHOWED: WBC 6.6*10.9/L, CRP 76.4MG/L, ESR 47MG/L AND WAS GIVEN PIPERCILLIN AND TAZOBACTAM 4.5G INTRAVENOUS DRIP INFUSION FOR ANTI-INFECTION. THE BODY TEMPERATURE IMPROVED, AND THE PATIENT WAS DISCHARGED. THE PATIENT HAD A MILD ANEMIA ON AN UNKNOWN DATE AND IS ONGOING, UNCHANGED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DELIRIUM AND WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. THE PATIENT DEVELOPED FEVER AGAIN ON MAY 12, WITH A BODY TEMPERATURE UP TO 38C. FOR FURTHER DIAGNOSIS AND TREATMENT, THE PATIENT WAS ADMITTED TO THE INFECTIOUS DISEASE DEPARTMENT WITH A DIAGNOSIS OF RECURRENT FEVER FOR OVER TWO MONTHS. AFTER ADMISSION, A ROUTINE BLOOD TEST SHOWED: WBC 6.5*10.9/L, HEMOGLOBIN 91G/L, NEUTROPHIL PERCENTAGE 65.7%, PLATELET COUNT 183*10^9/L, C-REACTIVE PROTEIN 64.3MG/L, ALBUMIN 27.7G/L. COMPUTED TOMOGRAPHY (CT) SCAN OF THE CHEST, RIGHT FEMUR, AND WHOLE ABDOMEN SUGGESTED DORSAL HYPOSTATIC CHANGES AT BILATERAL LOWER LOBES WITH A SMALL AMOUNT OF PLEURAL EFFUSION ON BOTH SIDES. THE PATIENT WAS GIVEN MEROPENEM, PIPERCILLIN AND TAZOBACTAM, AND VANCOMYCIN SUCCESSIVELY AS ANTI-INFECTIVE TREATMENT, MASSIVE FLUID REPLACEMENT, AND ASYMPTOMATIC AND SUPPORTIVE TREATMENTS SUCH AS STOMACH PROTECTION AND IRON SUPPLEMENT. THE PATIENT¿S HIGHEST BODY TEMPERATURE WAS 40C. ON (B)(6) 2019, THE PATIENT PRESENTED THYROID NODULE AND IS ONGOING, UNCHANGED; ALSO DEVELOPED SKIN INFECTION. EVENTUALLY, THE PATIENT DID NOT HAVE FEVER, COUGH OR EXPECTORATION, CHEST TIGHTNESS OR CHEST PAIN, OR OTHER DISCOMFORTS. DURING THE WINDOW PERIOD OF VISIT 4, THE INVESTIGATOR CALLED THE PATIENT MULTIPLE TIMES FOR FOLLOW-UP AND ALL FAILED TO REACH THE PATIENT. AFTER THE WINDOW PERIOD, THE INVESTIGATOR REACHED THE PATIENT¿S FAMILY ONCE BY PHONE, BUT THE PATIENT¿S FAMILY REFUSED TO VISIT THE HOSPITAL, ASKED IF X-RAY FILMS FROM ANOTHER HOSPITAL CAN BE USED FOR DIAGNOSIS AND GOT AN ANSWER OF NO, THEREFORE, THIS PATIENT WAS LOST OF FOLLOW-UP FOR VISIT 4. DURING THE WINDOW PERIOD OF VISIT 5, THE INVESTIGATOR ALSO CALLED THE PATIENT MULTIPLE TIMES FOR FOLLOW-UP AND AGAIN FAILED TO REACH THE PATIENT. THIS AE WAS FOUND DURING THE TELEPHONE FOLLOW-UP ON (B)(6) 2019. THE PATIENT HAD A SEVERE PLEURAL EFFUSION ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT PRESENTED URINARY TRACT INFECTION AND THE REPORTED ADVERSE EVENT WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. THE REPORTED ADVERSE EVENT FOR SKIN INFECTION AND PLEURAL EFFUSION WAS RESOLVED WITHOUT SEQUELA ON (B)(6) 2019. THE PATIENT WAS ADMITTED ON AN UNKNOWN DATE AND DURING THE HOSPITAL STAY, THE PATIENT WAS GIVEN STOMACH PROTECTION, ANTI-INFECTION, CHEST DRAINAGE AND OTHER TREATMENTS. AT DISCHARGE, THE PATIENT DID NOT HAVE FEVER, COUGH OR EXPECTORATION, CHEST TIGHTNESS OR PAIN, OR OTHER DISCOMFORTS. THE PATIENT¿S CONDITION WAS STABLE AND WAS DISCHARGED ON (B)(6) 2019. THE PATIENT WAS INSTRUCTED TO VISIT THE LOCAL HOSPITAL FOR MEROPENEM INJECTION 0.5 INTRAVENOUS DRIP, ONCE DAILY FOR 5 DAYS AND FOLLOW UP LEFT PLEURAL FLUID AND WILL RECEIVE CATHETERIZATION AND DRAINAGE IF THERE IS A GREAT AMOUNT OF PLEURAL FLUID. ON (B)(6) 2019, THE INVESTIGATOR CALLED THE PATIENT BY PHONE AND FOUND THAT THE PATIENT WAS STILL EXPERIENCING HYPERPYREXIA REPEATEDLY AND STAYED IN THE LOCAL HOSPITAL FOR CONTINUED ANTI-INFECTION THERAPY WITH MEROPENEM INJECTION.
510K: THIS REPORT IS FOR AN UNKNOWN NAIL HEAD ELEMENTS: TFNA HELICAL BLADE/UNKNOWN LOT NUMBER. WITHOUT THE SPECIFIC PART NUMBER, THE UDI NUMBER AND 510K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT ACCIDENTALLY FELL AT HOME WITHOUT PASSING OUT. THE PATIENT IMMEDIATELY FELT PAIN OVER THE RIGHT HIP AND COULD NOT GET UP, BUT DID NOT HAVE HEADACHE, DIZZINESS OR DEFORMITY OF THE LIMBS. THE PATIENT WAS SENT TO A LOCAL HOSPITAL WHERE AN X-RAY WAS TAKEN WHICH SUGGESTED A RIGHT INTERTROCHANTERIC FRACTURE AND WAS GIVEN SYMPTOMATIC TREATMENT. (B)(6) 2019, THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT OF THE HOSPITAL. A PHYSICAL EXAMINATION (PE) WAS PERFORMED AND ANOTHER X-RAY WAS TAKEN AND RESULTED THE SAME. THE PATIENT¿S CONDITION DID NOT CHANGE WHILE WAITING FOR ADMISSION. (B)(6) 2019, AN INFORMED CONSENT FORM FOR ¿A PROSPECTIVE STUDY ON THE EVALUATION OF METAL INTRAMEDULLARY NAIL SYSTEM IN CHINESE PATIENTS¿ WAS SIGNED. THE PATIENT¿S EXAMINATION RESULTS MET THE INCLUSION CRITERIA AND DID NOT MEET ANY OF THE EXCLUSION CRITERIA. IT WAS RANDOMIZED AT 10:19 AM AND ALLOCATED TO THE TEST GROUP (TFNA), WITH A RANDOM NUMBER OF 194. THE PATIENT UNDERWENT AN INTERNAL FIXATION OF FEMORAL INTERTROCHANTERIC FRACTURE ON (B)(6) 2019, POSTOPERATIVELY, THE PATIENT WAS GIVEN ANTI-INFECTION AND ANTICOAGULANT MEDICATIONS UTILIZING TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SYSTEM. REPORTEDLY, THE PATIENT EXPERIENCED MODERATE INCISION PAIN AND HIGH BLOOD PRESSURE ON (B)(6) 2019. THE PATIENT WAS GIVEN A MEDICATION FOR INCISION PAIN AND HIGH BLOOD PRESSURE AND THE REPORTED ADVERSE EVENT WAS RESOLVED WITHOUT SEQUELA. (B)(6) 2019, THE PATIENT¿S CONDITION WAS GOOD AND WAS DISCHARGED WITH MEDICATIONS. HOWEVER, AFTER BEING DISCHARGED, THE PATIENT DEVELOPED FEVER SYMPTOMS WITHOUT A NOTICEABLE INCENTIVE AND GOT ADMITTED WITH A BODY TEMPERATURE THAT RANGED UP TO 38¿C ON AN UNKNOWN DATE. THE PATIENT DID NOT HAVE CHILLS, SHIVER, COUGH OR EXPECTORATION, CHEST TIGHTNESS OR BREATHLESSNESS, ABDOMINAL PAIN OR DIARRHEA, FREQUENT URGENT OR PAINFUL MICTURITION, OR SYSTEMIC MUSCLE SORENESS. AN ANTI-INFECTIVE TREATMENT WAS ADMINISTERED, AND THE BODY TEMPERATURE RETURNED TO NORMAL AND THE PATIENT GOT DISCHARGED ON AN UNKNOWN DATE. A WEEK AFTER BEING DISCHARGED, THE PATIENT DEVELOPED FEVER AGAIN WITH A BODY TEMPERATURE UP TO 40¿C AND WAS ADMITTED. A ROUTINE BLOOD TEST SHOWED: WHITE BLOOD CELL (WBC) 5.5*10.9/L, CRP 147MG/L, ESR 86MG/L. CEFTRIAXONE 2G INTRAVENOUS DRIP INFUSION WAS GIVEN FOR ANTI-INFECTION, AND THE BODY TEMPERATURE IMPROVED, AND THE PATIENT WAS DISCHARGED. TWO WEEKS AFTER DISCHARGE, THE PATIENT DEVELOPED FEVER AGAIN WITH THE BODY TEMPERATURE UP TO 39¿C AND GOT ADMITTED WERE A ROUTINE BLOOD TEST SHOWED: WBC 6.6*10.9/L, CRP 76.4MG/L, ESR 47MG/L AND WAS GIVEN PIPERCILLIN AND TAZOBACTAM 4.5G INTRAVENOUS DRIP INFUSION FOR ANTI-INFECTION. THE BODY TEMPERATURE IMPROVED, AND THE PATIENT WAS DISCHARGED. (B)(6) 2019, THE PATIENT DEVELOPED FEVER AGAIN WITH A BODY TEMPERATURE UP TO 38¿C. FOR FURTHER DIAGNOSIS AND TREATMENT, THE PATIENT WAS ADMITTED TO THE INFECTIOUS DISEASE DEPARTMENT WITH A DIAGNOSIS OF RECURRENT FEVER FOR OVER TWO MONTHS. AFTER ADMISSION, A ROUTINE BLOOD TEST SHOWED: WBC 6.5*10.9/L, HEMOGLOBIN 91G/L, NEUTROPHIL PERCENTAGE 65.7%, PLATELET COUNT 183*10^9/L, C-REACTIVE PROTEIN 64.3MG/L, ALBUMIN 27.7G/L. COMPUTED TOMOGRAPHY (CT) SCAN OF THE CHEST, RIGHT FEMUR, AND WHOLE ABDOMEN SUGGESTED DORSAL HYPOSTATIC CHANGES AT BILATERAL LOWER LOBES WITH A SMALL AMOUNT OF PLEURAL EFFUSION ON BOTH SIDES. AFTER ADMISSION, THE PATIENT WAS GIVEN MEROPENEM, PIPERCILLIN AND TAZOBACTAM, AND VANCOMYCIN SUCCESSIVELY AS ANTI-INFECTIVE TREATMENT, MASSIVE FLUID REPLACEMENT, AND ASYMPTOMATIC AND SUPPORTIVE TREATMENTS SUCH AS STOMACH PROTECTION AND IRON SUPPLEMENT. THE PATIENT¿S HIGHEST BODY TEMPERATURE WAS 40°C. NOW, THE PATIENT DID NOT HAVE FEVER, COUGH OR EXPECTORATION, CHEST TIGHTNESS OR CHEST PAIN, OR OTHER DISCOMFORTS. DURING THE WINDOW PERIOD OF VISIT 4, THE INVESTIGATOR CALLED THE PATIENT MULTIPLE TIMES FOR FOLLOW-UP AND ALL FAILED TO REACH THE PATIENT. AFTER THE WINDOW PERIOD, THE INVESTIGATOR REACHED THE PATIENT¿S FAMILY ONCE BY PHONE, BUT THE PATIENT¿S FAMILY REFUSED TO VISIT THE HOSPITAL, ASKED IF X-RAY FILMS FROM ANOTHER HOSPITAL CAN BE USED FOR DIAGNOSIS AND GOT AN ANSWER OF NO, THEREFORE, THIS PATIENT WAS LOST OF FOLLOW-UP FOR VISIT 4. DURING THE WINDOW PERIOD OF VISIT 5, THE INVESTIGATOR ALSO CALLED THE PATIENT MULTIPLE TIMES FOR FOLLOW-UP AND AGAIN FAILED TO REACH THE PATIENT. THIS AE WAS FOUND DURING THE TELEPHONE FOLLOW-UP ON (B)(6) 2019. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE. THIS REPORT IS 2 OF 3 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 465137 | UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE | NAIL, FIXATION, BONE | JDS | DAI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Required Intervention | UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE| UNK - NAILS: TFNA| UNK - SCREWS: LOCKING |