BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SLIDING INSERT F/AIMING ARM F/PF

    MDR report key: 3968538 · Received July 30, 2014

    Report

    Report Number
    2520274-2014-12955
    Event Type
    Malfunction
    Date Received
    July 30, 2014
    Report Date
    July 7, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: INTRAOPERATIVE UNDER PRESSURE THE LOCKING MECHANISM IS LOOSENING FROM THE PROXIMAL FEMORAL NAIL ANTIROTATION AIMING ARM. NO OTHER INFORMATION WAS PROVIDED FOR THIS EVENT THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445331 LOCKING SLIDING INSERT F/AIMING ARM F/PF GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1