LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM
Report
- Report Number
- 2939274-2018-50016
- Event Type
- Injury
- Date Received
- January 2, 2018
- Date of Event
- September 17, 2016
- Report Date
- December 4, 2017
- Manufacturer
- WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
- Product Code
- HRS
- PMA / PMN Number
- K011335
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: 241.371, LOT NUMBER: H061661: PART MANUFACTURE DATE: 17-MAR-2016, MANUFACTURING LOCATION: ELMIRA, PART EXPIRATION DATE: N/A . DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED ONE NONCONFORMANCE (NC) ASSOCIATED WITH BP82 RAW MATERIAL LOT H026110. NR WAS GENERATED DUE TO THE RAW MATERIAL BARS CONTAINING DEBRIS ON THE SURFACE. THIS NC WAS NOT CONFIRMED AS LIGHT SHOP GRIME FROM THE SUPPLIER PROCESS IS ACCEPTABLE AS LONG AS IT DOES NOT AFFECT THE MATERIAL. THEREFORE, ALL RAW MATERIAL BARS FROM BP82 RAW MATERIAL LOT H026110 WERE RELEASED FROM HOLD AS CONFORMING. SINCE THE BARS FROM BP82 RAW MATERIAL LOT H026110 WERE CONFORMING AND RELEASED FROM HOLD, NR IS NOT RELEVANT TO THIS COMPLAINT. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DATE REPORTED INCORRECTLY ON THE INITIAL MEDWATCH MWR-08122017-0000019564, THE CORRECT DATE SHOULD BE (B)(6) 2017. 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. 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.
FURTHER IT WAS REPORTED THAT THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT SOMETIME IN (B)(6) OF 2016, AND UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF HER LEFT WRIST ON (B)(6) 2016 AS TREATMENT FOR HER FRACTURE. DURING THIS PROCEDURE THE PATIENT WAS IMPLANTED WITH AN LCP ONE-THIRD TUBULAR PLATE. THE PATIENT CLAIMS THAT HER RECOVERY WAS PROGRESSING FOLLOWING THE INITIAL PROCEDURE. HOWEVER, ON THE MORNING OF (B)(6) 2016 SHE WOKE UP WITH SEVERE PAIN AND A BUMP ON HER WRIST. X-RAYS TAKEN ON (B)(6) 2016 REVELED A FRACTURED PLATE AND DISPLACED FRACTURE.
IT WAS REPORTED THAT IN THE MORNING OF (B)(6) 2016, PATIENT WOKE UP WITH SEVERE PAIN AND A BUMP ON HER LEFT WRIST. RADIOLOGY OF LEFT WRIST TAKEN ON (B)(6) 2016 SHOWED COMPLETE FRACTURE OF THE MIDPORTION OF THE RADIAL PLATE HARDWARE WITH DISPLACEMENT OF FRACTURE FRAGMENTS BY APPROXIMATELY 6MM. RADIOLOGY OF LEFT FOREARM TAKEN ON (B)(6) 2016 SHOWED DISTAL ULNAR FRACTURE WITH MODERATE DISPLACEMENT. ON (B)(6) 2016, PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AND SUSTAINED FRACTURE IN THE LEFT ARM WHICH WAS INITIALLY TREATED WITH SPLINT AND CAST. ON (B)(6) 2016, PATIENT WENT TO THE EMERGENCY ROOM WITH COMPLAINTS OF PAIN IN THE LEFT ARM DESCRIBED AS ACHING, SHARP, NON-RADIATING AND WORSENING WITH MOVEMENT OF THE EXTREMITY. PAIN SCORE WAS 10 OUT OF 10. PATIENT ALSO HAD HEADACHE AND NECK PAIN NOT RELIEVED BY MEDICATIONS. THERE WAS RIGHT HIP PAIN THAT WAS DUE TO LARGE BRUISE OF THE AREA AND A RIGHT ELBOW PAIN FROM STAPLE PLACEMENT. PAIN PARTIALLY RELIEVED AFTER RECEIVING INTRAMUSCULAR TORADOL MEDICATION. SAME DAY RADIOLOGY OF LEFT ARM SHOWED DISPLACED TRANSVERSE FRACTURES OF THE RADIUS AND ULNA IN THE MIDSHAFT OR DISTAL DIAPHYSEAL PORTIONS OF THE BONES. MILD VENTRAL ANGULAR DEFORMITY WAS SEEN AT THE RADIAL FRACTURE SITE. 2 SMALL LOOSE BONY FRAGMENTS WAS OBSERVED. ON (B)(6) 2016, PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE MIDSHAFT OF LEFT RADIUS AND ULNA AND WAS IMPLANTED WITH AN LCP ONE-THIRD TUBULAR PLATE. THE PATIENT CLAIMED THAT HER RECOVERY WAS PROGRESSING FOLLOWING THE INITIAL PROCEDURE. ON (B)(6) 2016, PATIENT EXPERIENCED SEVERE PAIN AND BUMP ON HER LEFT WRIST. ON (B)(6) 2016, PATIENT WENT TO THE EMERGENCY ROOM WITH COMPLAINTS OF PAIN IN HER LEFT WRIST. PAIN SEVERITY WAS 8 OUT 10. PAIN WAS ON AND OFF FOR A WEEK THAT WORSENED THE NIGHT PRIOR TO ER VISIT. PAIN DESCRIBED AS SHARP IRRITATING, ACHING PAIN THAT IS WORSE WITH STRAINING. DENIES ANY NAUSEA, VOMITING, DIARRHEA, FEVER, CHILLS, HEADACHE, RASHES, SHORTNESS OF BREATH OR LOSS OF CONSCIOUSNESS. DENIES ANY INJURY OR TRAUMA. PHYSICAL EXAM SHOWED PAIN AND SWELLING LEFT FOREARM, TENDER SWOLLEN LEFT FOREARM, NO NEUROMUSCULAR COMPROMISE, DECREASED RANGE OF MOTION OF LEFT FOREARM AND HAND. SAME DAY RADIOLOGY OF LEFT WRIST SHOWED INTERVAL PLACEMENT OF PLATE AND SCREW FIXATION OF FRACTURE THROUGH THE DIAPHYSIS OF THE ULNA AND RADIUS. THE ULNAR PLATE AND SCREW IS INTACT, HOWEVER THERE IS A COMPLETE FRACTURE OF THE MIDPORTION OF THE RADIAL PLATE WITH DISPLACEMENT OF FRACTURE FRAGMENTS BY APPROXIMATELY 6MM. MILD DIFFUSE OSTEOPENIA. THE JOINT SPACES ARE INTACT. NO SIGNIFICANT OSSEOUS LESIONS ARE IDENTIFIED. THE SCAPHOLUNATE INTERVAL IS WITHIN NORMAL LIMITS. THE SOFT TISSUES ARE UNREMARKABLE. ON (B)(6) 2016, RADIOLOGY OF LEFT FOREARM SHOWED COMPLETE DISPLACED FRACTURE OF THE MIDPORTION OF THE RADIAL PLATE WITH ASSOCIATED NEW FRACTURE OF THE MID RADIAL DIAPHYSIS. PLATE AND SCREW FIXATION OF MID ULNAR FRACTURE IS INTACT, HOWEVER THERE IS INCOMPLETE HEALING OF TRABECULAR FRACTURE COMPONENTS. DIFFUSE OSTEOPENIA. NO SIGNIFICANT DEGENERATIVE CHANGES. NO OSSEOUS LESIONS IDENTIFIED. SOFT TISSUES ARE UNREMARKABLE. CLINICAL IMPRESSION WERE ACUTE CLOSED LEFT DISPLACED MID-SHAFT RADIAL FRACTURE AND BROKEN ORTHOPEDIC PLATE ON MID-SHAFT FRACTURE OF LEFT RADIUS. ON (B)(6) 2016, PATIENT UNDERWENT REVISION OF LEFT RADIUS PLATE AND SCREW FIXATION. IT WAS UNKNOWN IF A SYNTHES DEVICE WAS USED FOR REVISION.
PATIENT AGE OR DATE OF BIRTH AND WEIGHT NOT AVAILABLE FOR REPORTING. 510K: THIS REPORT IS FOR AN UNKNOWN PLATE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS ATTORNEY. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 OR ABOUT (B)(6) 2016 THE PATIENT EXPERIENCED PAIN AND WAS INJURED BY AN UNKNOWN SURGICAL REPAIR PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1148 | LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM | PLATE, FIXATION, BONE | HRS | WRIGHTS LANE : SYNTHES USA PRODUCTS LLC | H061661 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |