BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JEWELERS CAP HANDLE W/ QUICK COUPLING

    MDR report key: 21101987 · Received January 8, 2025

    Report

    Report Number
    3020584246-2025-00011
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    January 1, 2024
    Manufacturer
    SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC
    Product Code
    LXH
    UDI-DI
    00810112592733
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY REVIEW: PRODUCT CODE: : 03.900.325. LOT NUMBER : BR696617. RELEASE TO WAREHOUSE DATE : 15 NOV 2024. EXPIRATION DATE : NA. SUPPLIER: NA. MANUFACTURING SITE: CROSSROADS EXTREMITY SYSTEMS, LLC. 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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 AN UNKNOWN DATE, DURING AN ORIF OF A FEMUR, A DHS 6H WAS USED AND THE PLATE DID NOT SEAT ON THE T HANDLE DHS INSERTER. UNSURE WHAT WAS WRONG WITH PLATE. TSP WAS USED AND THE SM HEXAGONAL PELVIC SCRDRIVER/LRG HNDL WAS USED TO BEND THE PLATE AND THE SHAFT ENDED UP BENDING AS WELL. TWO OF THE DEVICES WERE BENT. THE CABLES WERE USED AND THE CABLE LOCK WOULD NOT LOCK. ALSO, THE RATCHETING DRIVER HAD A 3.5 HEX STUCK AND UNABLE TO TAKE OUT. THERE WAS NO PATIENT CONSEQUENCE. IT WAS FURTHER REPORTED THAT THE COUPLING MECHANISM USED WERE THE JEWELERS CAP HANDLE WITH QUICK COUPLING AND THE SMALL RATCHET HANDLE WITH QUICK COUPLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236023 JEWELERS CAP HANDLE W/ QUICK COUPLING ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC BR696617 00810112592733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown