BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI END CAP FOR TFNA 0MM EXTN ¿ STERILE

    MDR report key: 19470179 · Received June 5, 2024

    Report

    Report Number
    8030965-2024-07121
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 10, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K160167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    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: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: INITIAL REPORTER IS A DEPUYSYNTHES SALES REPRESENTATIVE H3, H4, H6: PART 04.038.000S, LOT 8664P95: MANUFACTURING SITE:JABIL BETTLACH. THE PRODUCT WAS RELEASED ON: JANUARY 08, 2024. EXPIRY DATE: JANUARY 01, 2034. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR A FEMORAL TROCHANTERIC FRACTURE. THE SURGEON INSERTED THE NAIL, LAG SCREW, AND INJECTED CEMENT. AFTER THAT, THE SURGEON INSERTED THE LOCKING SCREW AND ATTEMPTED TO INSERT THE END CAP, BUT THE END CAP COULD NOT BE INSERTED. THE SURGEON CONFIRMED THAT THE END CAP WAS INSERTED IN THE PROPER DIRECTION, BUT THE END CAP COULD NOT BE ENGAGED WITH THE NAIL. THE SURGEON TOOK OUT THE END CAP ONCE AND CHECKED IF THE LOCKING MECHANISM WAS TIGHTENED PROPERLY. THERE WAS NO PROBLEM WITH THE LOCKING MECHANISM. THE SURGEON USED A SPARE END CAP, BUT THE SPARE END CAP COULD NOT BE PROPERLY ENGAGED WITH THE NAIL EITHER. THE SURGEON COMPLETED THE PROCEDURE WITHOUT AN END CAP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY (30) MINUTE DELAY. THE PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. THIS REPORT IS FOR AN END CAP. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802078 TI END CAP FOR TFNA 0MM EXTN ¿ STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 8664P95

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 10/125 DEG TI CANN TFNA 235/LEFT - SILE| TFNA END CAP EXTENS. 0 TAN