BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 2942971 · Received February 5, 2013

    Report

    Report Number
    3003787298-2013-00006
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. PRODUCT DEVELOPMENT ENGINEER EVALUATED THE DEVICE AND INDICATED THE HEX TIP HAS BROKEN OFF JUST ABOVE THE TRANSITION TO THE SHAFT. ONLY ONE JAGGED PORTION OF ONE SIDE OF THE HEX REMAINS IN TACT. SEVERAL WEAR MARKS EXIST ON THE SHAFT WHICH ARE CONSISTENT WITH FIELD USE. THE RETURNED DEVICE WAS MANUFACTURED IN NOVEMBER 1995 AND IS OVER 17 YEARS OLD. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE ROOT CAUSE OF THE ISSUE. AS PART OF THE CORRECTIVE ACTION, THE MATERIAL WAS CHANGED FROM 440A STAINLESS STEEL TO 465PH STAINLESS STEEL AND WAS IMPLEMENTED ON SHAFT (314.05.01) LOT NUMBERS 4487955 AND 4480644. THE SHAFT (314.05.01) ON THIS COMPLAINT IS LOT# A4EF091 AND WAS MANUFACTURED IN NOVEMBER 1995 PRIOR TO IMPLEMENTATION OF THE CORRECTIVE ACTION. THE DESIGN RISK ASSESSMENT WAS REVIEWED AND FOUND TO BE ADEQUATE FOR THE INTENDED USE. THE DHR WAS REVIEWED AND NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DURING SURGERY FOR A PROXIMAL LEFT FEMUR FRACTURE, WHILE TRYING TO INSERT A SCREW, THE TIP OF THE CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHEARED OFF. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE. THIS HAPPENED ON THE 2ND OUT OF 3 SCREWS AND THERE WERE NO REPORTED ISSUES WITH THE OTHER SCREWS. PER THE SALES CONSULTANT, IT WAS AN OLD SCREW DRIVER ABOUT 10 YEARS OLD. THERE WAS NO ADVERSE EFFECT TO THE PATIENT AND SURGERY WAS NOT PROLONGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49096 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER HEXAGONAL SCREWDRIVER HXX SYNTHES JENNERSVILLE A4EG739

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR