BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3501552 · Received December 5, 2013

    Report

    Report Number
    3003787298-2013-00111
    Event Type
    Malfunction
    Date Received
    December 5, 2013
    Report Date
    November 11, 2013
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DHR WAS REVIEWED AND NONCONFORMANCE WAS FOUND ON P/N 357.402.4 LOT #5008315 FOR DRAWING NOT CLEAR WHERE MEASUREMENT TO BE TAKEN FOR FEATURE L6. THE QE ACCEPTED THE PARTS AS CONFORMS AFTER 100% INSPECTION WAS PERFORMED AND PASSED. THIS NONCONFORMANCE IS NOT RELEVANT TO THIS COMPLAINT BECAUSE THE ISSUE IS ON THE HOOK NOT THE BALL COMPONENT. NONCONFORMANCE WAS FOUND ON P/N 357.402.4 LOT #5014274 FOR INSPECTION NOT PERFORMED, DRAWING NOT CLEAR FOR AREA OF MEASUREMENT FOR FEATURE L6. THE QE ACCEPTED THE PARTS AS CONFORMS AFTER 100% INSPECTION WAS PERFORMED AND PASSED. THIS NONCONFORMANCE IS NOT RELEVANT TO THIS COMPLAINT BECAUSE THE ISSUE IS ON THE HOOK NOT THE BALL COMPONENT. NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Description of Event or Problem · 1

    SALES CONSULTANT REPORTED THAT IN THE PROCESS OF ORDINARY MAINTENANCE AND ASSEMBLY OF THE LOCKING DEVICE FOR TFN SET, IT WAS DISCOVERED THAT THE INSTRUMENT IS PARTIALLY BROKEN. CONSULTANT STATED THAT A BALL BEARING FOR THE INNER SLEEVE OF THE DEVICE HAS COME LOOSE WHICH MADE THE INNER SLEEVE UNSTABLE AND CAPABLE OF FALLING. THE INSTRUMENT WAS NOT INVOLVED IN A PROCEDURE AND WAS PART OF THE FIELD UNIT BELONGING TO CONSULTANT. THIS IS REPORT ONE OF ONE FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631389 LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS HTJ SYNTHES JENNERSVILLE 5057568

    Patients

    Seq Age Sex Outcome Treatment
    1