BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMER 500 GRAMS

    MDR report key: 5464487 · Received February 26, 2016

    Report

    Report Number
    1719045-2016-10167
    Event Type
    Malfunction
    Date Received
    February 26, 2016
    Date of Event
    January 31, 2016
    Report Date
    February 1, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    FZY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A SERVICE HISTORY REVIEW WAS ATTEMPTED ON: PART NO. 399.42, SERIAL/LOT NO: (B)(4)/5133451 NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 12-DEC-2005. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. A REVIEW OF THE SERVICE & REPAIR HISTORY HAS BEEN REQUESTED AND THE RESULTS ARE PENDING COMPLETION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    SERVICE AND REPAIR EVALUATION - THE CUSTOMER REPORTED THE ITEM BROKE. THE REPAIR TECHNICIAN REPORTED THE HANDLE SHAFT WAS BROKEN. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. (B)(4). 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

    IT WAS REPORTED THAT TWO TROCHANTERIC FIXATION NAIL (TFN) PIECES BROKE DURING A CASE ON (B)(6) 2016. NO PATIENT INJURY NOR DELAY IN THE CASE OCCURRED. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119297 HAMMER 500 GRAMS HAMMER,SURGICAL FZY SYNTHES TUTTLINGEN 5133451

    Patients

    Seq Age Sex Outcome Treatment
    1