BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT

    MDR report key: 2993688 · Received March 7, 2013

    Report

    Report Number
    2530088-2013-00278
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE RETURNED DEVICE WAS MANUFACTURED IN JULY 1999 AND IS OVER 13 YEARS OLD. THE HEX TIP HAS SHEARED OFF AND WAS NOT RETURNED FOR EVALUATION. THE FRACTURE FACE IS MOSTLY EVEN WITH ONE JAGGED SEGMENT. WEAR MARKS AND DISCOLORATION EXIST ON THE ENTIRE DEVICE, WHICH IS CONSISTENT WITH FIELD USE FOR OVER 13 YEARS. BASED ON THE AGE AND CONDITION OF THE RETURNED DEVICE, THIS DEVICE HAS OUTLIVED IT USEFUL LIFE. THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DURING A PROCEDURE ON AN UNKNOWN DATE, AS SURGEON WAS INSERTING A 6.5 CANNULATED SCREW, THE CANNULATED SCREWDRIVER SHAFT BROKE. A REPLACEMENT SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE AS INTENDED. ALL FRAGMENTS WERE RETRIEVED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97309 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT HXX SYNTHES BRANDYWINE A4JW985

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR