BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 3943321 · Received July 18, 2014

    Report

    Report Number
    1719045-2014-10319
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 23, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: DUE TO AN UNKNOWN CAUSE, THE THREADS AT THE END OF THE INSTRUMENT HAVE BROKEN/SNAPPED OFF. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS NOT MANUFACTURING-RELATED.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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED RMS COMPANY MANUFACTURED THE LOCKING HOLDING SLEEVE ¿ LONG FOR MATRIX, FOR SYNTHES P/N 03.616.043, AND LOT NUMBER 6921274 FOR PO 1373984. THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE (DATED 10/25/12) INDICATES THE PARTS WERE MANUFACTURED TO P/N 03.616.042, REVISION ¿D¿ AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES, TABULATED INCOMING FINAL INSPECTION SHEET NUMBER NS054040, REVISION ¿D¿ (COMPLETED 12/5/12). THERE WERE NO MATERIAL REVIEW REPORTS, NONCONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT. DRAWING 03.616.042 REV ¿D¿ WAS RELEASED APRIL 18, 2012. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE THREADS AT THE END OF THE INSTRUMENT HAVE BROKEN/SNAPPED OFF. THE DAMAGE WAS REPORTED BY THE STERILIZATION DEPARTMENT BUT NO ONE IS ABLE TO IDENTIFY HOW OR WHEN IT HAPPENED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423282 LOCKING HOLDING SLEEVE-LONG FOR MATRIX MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6921274

    Patients

    Seq Age Sex Outcome Treatment
    1