PEDIATRIC LCP(TM) HIP PLATE 3.5MM 120°-STERILE
Report
- Report Number
- 8030965-2024-02613
- Event Type
- Malfunction
- Date Received
- February 19, 2024
- Manufacturer
- SYNTHES GMBH
- Product Code
- HRS
- PMA / PMN Number
- K112085
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
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. H3, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. PART # 02.108.313S, LOT # L890543 , MANUFACTURING SITE: WERK SELZACH LOGISTIK, RELEASE TO WAREHOUSE DATE: 07.MAY.2018, EXPIRATION DATE: 01.MAY.2028, SUPPLIER: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART # 02.108.313, NON-STERILE LOT # L852482, MANUFACTURING SITE: WERK RARON, RELEASE TO WAREHOUSE DATE: 16 APRIL 2018, SUPPLIER: N/A. PHOTOS WERE PROVIDED FOR REVIEW, HOWEVER THEY DO NOT REPRESENT THE REPORTED COMPLAINT CONDITION. THEREFORE, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. THE LCP PAED-HIPPL 3.5 120° W/19 L75 HAS EVIDENCE OF NORMAL USE. FUNCTIONALITY ISSUES CANNOT BE ASSESSED THROUGH A PHOTO INVESTIGATION. THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR LCP PAED-HIPPL 3.5 120° W/19 L75 THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS 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: D2: ADDITIONAL PROCODES: HWC, JDS. D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. E3: INITIAL REPORTER IS A SYNTHES EMPLOYEE. H3, H6: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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. 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. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT SCRATCHES WERE OBSERVED ON THE SURFACE OF THE LCP PAED-HIPPL 3.5 120° W/19 L75 WHICH COULD HAVE BEEN A RESULT OF IMPLANTATION, HOWEVER; THE OBSERVED CONDITION COULD NOT CONTRIBUTE TO ALLEGED REPORTED CONDITION. NO OTHER ISSUES WERE IDENTIFIED. PER THE SURGICAL TECHNIQUE GUIDE, ¿NOTE: DO NOT FULLY INSERT THE LOCKING SCREWS BY POWER. ALWAYS PERFORM FINAL TIGHTENING BY HAND USING THE SCREWDRIVER HANDLE, TORQUE LIMITING ATTACHMENT AND SCREWDRIVER SHAFT. THE SCREW IS SECURELY LOCKED TO THE PLATE WHEN A CLICK IS HEARD.¿ A DIMENSIONAL INSPECTION FOR THE LCP PAED-HIPPL 3.5 120° W/19 L75 WAS NOT PERFORMED AS IT IS NOT APPLICABLE TO REPORTED CONDITION. A FUNCTIONAL TEST WAS PERFORMED WITH THE MATING DEVICE (LOCKSCR ø3.5 SELF-TAP L40 SST) AND THE SCREW WAS ABLE TO LOCK IN EACH LOCKING HOLE. THE COMPLAINT CONDITION WAS NOT ABLE TO BE REPLICATED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE LCP PAED-HIPPL 3.5 120° W/19 L75 WOULD NOT CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS 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.
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT FEMORAL SUBTRACTION OSTEOTOMY WITH PHP IMPLANT. ALL SCREWS USED IN THE PROCEDURE WERE LOCKING SCREWS, AND TORQUE LIMITING WAS APPLIED TO THEM. AFTER THE SURGERY, SCREWS IN PROXIMAL VENTRAL SIDE WERE LOOSE. ON (B)(6) 2024 ALL IMPLANTS WERE REMOVED, AND THEN A NEW PLATE AND SCREWS WERE INSERTED. WHEN THE FIRST PLATE AND SCREWS IN QUESTION WERE REMOVED, THE SURGEON DID NOT NOTICE THE FEELING OF UNLOCKING THE THREE PROXIMAL SIDE SCREWS. THEREFORE, IT WAS ASSUMED THAT ALL SCREWS IN THE PROXIMAL SIDE WERE LIKELY LOOSE. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A PEDIATRIC LCP(TM) HIP PLATE 3.5MM 120°. THIS IS REPORT 1 OF 4 FOR (B)(4).
THIS REPORT IS FOR ONE (1) PEDIATRIC LCP(TM) HIP PLATE 3.5MM 120°-STERILE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2085880 | PEDIATRIC LCP(TM) HIP PLATE 3.5MM 120°-STERILE | PLATE, FIXATION, BONE | HRS | SYNTHES GMBH | 02.108.313S | L852482 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | LCP PAED-HIPPL 3.5 120° W/19 L75| LOCKSCR ø3.5 SELF-TAP L40 SST| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING |