BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER SHAFT, COMPRESSION T2 TIBIA 3.5 MM

    MDR report key: 2679285 · Received July 27, 2012

    Report

    Report Number
    9610622-2012-00327
    Event Type
    Malfunction
    Date Received
    July 27, 2012
    Date of Event
    July 11, 2012
    Report Date
    July 11, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: (B)(4) COMPRESSION SCREW; ADVANCED T2 TIBIA, LOT# K102117; (B)(4) TIBIAL NAIL; STANDARD T2 TIBIA 13 X 315 MM, LOT# K891002.

    Description of Event or Problem · 1

    IT WAS REPORTED, DR IMPLANTED A TIBIAL NAIL IN A PT WITH A TRANSVERSE MID SHAFT FRACTURE. AFTER TIBIAL NAIL WAS IMPLANTED, HE PLACED TWO DISTAL SCREWS AND THEN PLACED A 5 MM SHAFT SCREW IN DYNAMIC POSITION OF PROXIMAL OBLONG HOLE. HE WENT AHEAD AND PLACED A TIBIA COMPRESSION SCREW DOWN THE NAIL AND ADVANCED IT TO THE SHAFT SCREW. UNDER IMAGE, DR TIGHTENED THE COMPRESSION SCREW AGAINST THE SHAFT SCREW. AFTER A FEW TURNS, THE HEAD OF COMPRESSION SCREWDRIVER SHAFT BROKE OFF INSIDE THE COMPRESSION SCREW. HE WAS ABLE TO GET ROUGHLY 3 MM OF COMPRESSION BEFORE THE BREAKAGE. HEAD OF COMPRESSION SCREWDRIVER SHAFT WAS LEFT INSIDE COMPRESSION SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER SHAFT, COMPRESSION T2 TIBIA 3.5 MM INSTRUMENT HXX STRYKER OSTEOSYNTHESIS KIEL NA K395198

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other