BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER

    MDR report key: 3171164 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02313
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO DAMAGE NOTED TO THE THREADS OF MAS HEAD THREADED INTERFACE. VISUALLY CONFIRMED APPROXIMATELY ~4 MM OF THE INSTRUMENT TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. DIMENSIONAL INSPECTION OF THE INNER SHAFT DIAMETER CONFIRMED CONFORMANCE TO PRINT SPECIFICATION. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD, CONSISTENT WITH TORSIONAL OVERLOAD CONDITION. THE ABOVE FINDINGS ARE CONSISTENT WITH TORSIONAL OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON TORQUED THE DRIVER TOO MUCH AND THE INNER SLEEVE AS WELL AS THE TIP BROKE. NO PATIENT COMPLICATIONS ARE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271280 SCREWDRIVER SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC NA RS12J005

    Patients

    Seq Age Sex Outcome Treatment
    1