BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREWDRIVER

    MDR report key: 4093951 · Received September 16, 2014

    Report

    Report Number
    1719045-2014-10445
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    April 24, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE CUSTOMER REPORTED THE INNER SHAFT BROKEN. THE REPAIR TECHNICIAN REPORTED TIP BROKEN AS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE INNER SHAFT WAS REPLACED. THIS ITEM WAS REPAIRED, PASSED FINAL INSPECTION AND RETURNED TO THE CUSTOMER ON (B)(4) 2014. 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 THE INNER SHAFTS WERE BROKEN ON THREE EXTRACTION SCREWDRIVER DEVICES. THE DEVICES REPORTEDLY BROKE DURING SCREW REMOVALS. THERE WAS NO DELAY TO SURGERY OR IMPACT TO THE PATIENT. NO PIECES WERE LEFT IN THE PATIENT AND ALL DISTAL TIP FRAGMENTS WERE DISCARDED WITH THE REMOVED SCREWS. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571413 EXTRACTION SCREWDRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 5102200

    Patients

    Seq Age Sex Outcome Treatment
    1