BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM/125 DEG TI CANN TFNA 200MM - STERILE

    MDR report key: 11392807 · Received March 1, 2021

    Report

    Report Number
    8030965-2021-01474
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    February 4, 2021
    Report Date
    February 4, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819650992
    PMA / PMN Number
    K160167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. D9 H3, H6: MANUFACTURING LOCATION: MONUMENT MANUFACTURING DATE: 22-JAN-2016 EXPIRATION DATE: 01-JAN-2026 PART NUMBER: 04.037.213S, 12MM/125 DEG TI CANN TFNA 200MM - STERILE LOT NUMBER: 9982328 (STERILE) LOT QUANTITY: 5 ONE PIECE WAS SCRAPPED IN CELL, QA FINAL INSPECT, FOR AN INNER DIAMETER COSMETIC NONCONFORMANCE. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE ONE PIECE NOTED. INSPECTION SHEET, IN-PROCESS/INSPECT DIMENSIONAL/FINAL MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE ONE PIECE NOTED. INSPECTION SHEET, TFNA ASSEMBLY INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG LPPF, LMD/LPF WAS REVIEWED AND DETERMINED TO BE CONFORMING. SCN 12153 SUPPLIED BY ETHICON (ABQ) WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART NUMBER: 04.037.912.2, LOCK PRONG, 125 DEGREE, TFNA, BP55 LOT NUMBER: 9761939 LOT QUANTITY: 96 PURCHASED FINISHED GOODS TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 04.037.912.4, WAVE SPRING, SHIM ENDED, BP55 LOT NUMBER: 9850941 LOT QUANTITY: 1,002 WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. MATERIAL CERTIFICATE AND CERTIFICATE OF CONFORMANCE AND QUALITY HISTORY CARD WERE REVIEWED AND DETERMINED TO BE CONFORMING. PART NUMBER: 04.037.912.3, TFNA LOCK DRIVE, BP58 LOT NUMBER: 9958757 LOT QUANTITY: 80 WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEETS MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 21127, TIMOAGRI16.00, BP80 LOT NUMBER: 7612628 LOT QUANTITY: (B)(4) LBS. CERTIFICATE OF ANALYSIS WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING / PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: TFNA FEM NAIL 12 125 L200 TI (PART# 04.037.213S, LOT# 9982328, QTY# 1) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE LOCK PRONG FROM THE DEVICE ASSEMBLY IS MISSING. THERE IS SLIGHT DISCOLORATION OBSERVED ON THE PROXIMAL THREADS WHICH SHOWS THERE WAS AN ATTEMPT MADE TO USE THE IMPLANT. SURFACE OF THE NAIL SHOWS FEW WATER MARKS WHICH WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. THUS, THE COMPLAINT IS BEING CONFIRMED. DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DOCUMENT(S) WAS REVIEWED: -TI CANNULATED TROCHANTERIC FIXATION NAIL-ADVANCED, 125 DEGREE -125 DEGREE LOCK PRONG ASSEMBLY TFNA NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE RECEIVED DEVICE WAS NOT PERFORMED AT CQ AS NO VISUAL DAMAGE WAS EVIDENT. COMPLAINT CONFIRMED? YES INVESTIGATION CONCLUSION: THE COMPLAINT IS BEING CONFIRMED FOR TFNA FEM NAIL 12 125 L200 TI (PART# 04.037.213S, LOT# 9982328) AS THE LOCK PRONG FROM THE DEVICE ASSEMBLY IS MISSING. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED PROBLEM. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED UPON THESE RESULTS, 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. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6), 2021, THE LOCKING MECHANISM WHICH SHOULD BE INCLUDED IN THE NAIL WAS MISSING, AND THE BLADE COULDN'T BE BLOCKED. ANOTHER TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL NEEDED TO BE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THIS RESULTED IN A SURGICAL DELAY OF FORTY-FIVE (45) MINUTES. THIS REPORT IS FOR A 12MM/125 DEGREE TITANIUM (TI) CANNULATED TFNA NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290805 12MM/125 DEG TI CANN TFNA 200MM - STERILE ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH 9982328 07611819650992

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE