TFNA FENESTRATED SCREW 105MM - STERILE
Report
- Report Number
- 8030965-2025-08462
- Event Type
- Malfunction
- Date Received
- August 15, 2025
- Date of Event
- January 1, 2025
- Manufacturer
- SYNTHES GMBH
- Product Code
- HSB
- UDI-DI
- 07611819652347
- PMA / PMN Number
- K160167
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: H3, H6: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. NOTE: FOLLOWING INVESTIGATION WAS PERFORMED BY THE MANUFACTURER. PLEASE REFER TO THE ACTION "A-141102 " FOR INVESTIGATION RESULTS. AS RECEIVED CONDITION: ONE PIECE OF PART NUMBER 04.038M205SP, BATCH/LOT 41595P5, WAS RECEIVED LOOSE IN A BAG WITHOUT ITS PACKAGING. THE PART IS LASER ETCHED WITH THE SYNTHES LOGO, CEO123, 04.038.205, 41595P5 AND 105MM. THE RECEIVED PART SHOWED COSMETIC SIGNS OF HANDLING, CONSISTING OF LIGHT SCRATCHES TO THE INTERIOR THREADS. FEATURES RELEVANT TO THE COMPLAINT CONDITION WERE INSPECTED FOR PART NUMBER 04.038M205SP, BATCH/LOT 41595P5. INSPECTION FEATURE SOURCE: PROCESS SHEET PS072812 REVISION R FEATURE: CANNULATION DRILL GAGE DESCRIPTION / ID: PIN GAGE GO / NO GO / HS 3.38-3.5 RESULT: GO (BOTH ENDS) CONCLUSION: PASS. SEE A-14110201 ATTACHMENT 1 HS 3.38 SCREW END LOT 41595P5 AND A-14110201 ATTACHMENT 2 HS 3.38 POCKET END LOT 41595P5. FEATURE: CANNULATION DRILL GAGE DESCRIPTION / ID: ¿GO¿ FUNCTION GAGE Ø3.25 CANNULATION TFN HELICAL BLADE / TFNA HELICAL BLADE AND SCREW / GT068753 RESULT: GO CONCLUSION: PASS. SEE A-14110201ATTACHMENT 3 GT068753 LOT 41595P5. FEATURE: CANNULATION TRUE POSITION GAGE DESCRIPTION / ID: FUNCTION GAGE CANNULATION LOCATION TFNA SCREW / TFNA HELICAL BLADE / GT066253 RESULT: GO CONCLUSION: PASS. SEE A-14110201ATTACHMENT 4 GT066253 LOT 41595P5. CONCLUSION: THE MANUFACTURING INVESTIGATION DETERMINED THAT THE COMPLAINT CONDITION IS NOT CONFIRMED. NO MANUFACTURING RELATED ISSUES WERE IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE TFNA SCR PERF L105 TAN WOULD NOT HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. 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 REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS 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. DEVICE HISTORY REVIEW PART# 04.038.205S LOT # 43660P6 MANUFACTURING SITE: WERK SELZACH LOGISTIK. SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 14 NOV 2024, EXPIRATION DATE: 01 NOV 2034. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT 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. H11 ADDITIONAL NARRATIVE: ADDED: H4 CORRECTED: G1. H3, H6: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. NOTE: FOLLOWING INVESTIGATION WAS PERFORMED BY THE MANUFACTURER. PLEASE REFER TO THE ACTION " A-14084438" FOR INVESTIGATION RESULTS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF TFNA FENESTRATED SCREW 105MM - STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NONCONFORMITIES NOTED. THIS LOT WAS SHIPPED TO MONUMENT FOR FINAL PACKAGING. 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. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NONCONFORMANCE NOTED. 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. THE MANUFACTURING INVESTIGATION DETERMINED THAT THE COMPLAINT CONDITION CANNOT BE CONFIRMED WITH THE EVIDENCE PROVIDED, AS THE COMPLAINT CONDITION OF: ¿THE HOLE IN THE SCREW WAS NOT CENTERED AND COULD NOT BE PROPERLY INSERTED.¿, IS UNDETERMINABLE VIA PHOTOGRAPHIC MEANS THAT DO NOT SHOW THE ACTUAL GAGING USED TO MANUFACTURE OR INSPECT THE PRODUCT. NO GAGING ASSOCIATED WITH THE DETERMINATION OF PRODUCT CONFORMANCE OR NONCONFORMANCE, PER PQP 04_038_170 OR PROCESS SHEET PS072812, IS SHOWN IN ANY OF THE THREE (3) PICTURES PROVIDED. NO MANUFACTURING RELATED ISSUES WERE IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE TFNA SCR PERF L105 TAN WOULD NOT HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J MEDTECH ORTHOPAEDICS QUALITY SYSTEM. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW PART# 04.038.205S LOT # 43660P6 MANUFACTURING SITE: WERK SELZACH LOGISTIK SUPPLIER: (B)(4) RELEASE TO WAREHOUSE DATE: 14 NOV 2024 EXPIRATION DATE: 01 NOV 2034. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT 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. H11 ADDITIONAL NARRATIVE: ADDED: D9, H4. H3, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, 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.
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.
IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE HOLE IN THE SCREW WAS NOT CENTERED AND COULD NOT BE PROPERLY INSERTED. THERE WAS NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2704516 | TFNA FENESTRATED SCREW 105MM - STERILE | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | SYNTHES GMBH | 43660P6 | 07611819652347 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |