BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT

    MDR report key: 3183322 · Received June 21, 2013

    Report

    Report Number
    2530088-2013-00977
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 25, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS RECEIVED FOR INVESTIGATION. THE RETURNED SCREWDRIVER SHAFT IS OVER 11 YEARS OLD. THE DISTAL HEX TIP OF THE RETURNED SCREWDRIVER SHAFT HAS SHEARED OFF MOSTLY EVENLY, EXCEPT FOR 2 JAGGED CORNERS EACH APPROXIMATELY 0.5MM LENGTH. THE BROKEN PIECE(S) OF THE TIP WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS MANUFACTURED TO THE CORRECT MATERIAL. THE DESIGN AND RISK ANALYSIS WAS REVIEWED AND IS ADEQUATE FOR ITS INTENDED USE. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    THE SCREWDRIVER SHAFT BROKE OFF DURING SURGERY AND THE FRAGMENT WAS REMOVED. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283868 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT SCREWDRIVERS HXX SYNTHES BRANDYWINE 4326206

    Patients

    Seq Age Sex Outcome Treatment
    1