BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, FULLY THREADED 5X35 MM

    MDR report key: 2419354 · Received December 8, 2011

    Report

    Report Number
    9610622-2011-00613
    Event Type
    Malfunction
    Date Received
    December 8, 2011
    Date of Event
    November 21, 2011
    Report Date
    November 22, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING SURGERY USING GAMMA3, THE SURGEON MEASURED THE SCREW (CAT#1890-5053S, LOT#K422349) BEFORE USE AS A ROUTINE, THEN ACCORDING TO HIM, IT WAS FOUND THAT THE SCREW HAS THE LENGTH OF 33MM TO 33.5MM WHEREAS IT SHOULD BE 35MM LONG. THUS, HE PICKED ANOTHER SCREW (CAT#1890-5053S, LOT#K397907) AND MEASURED, THEN IT WAS ALSO 33MM TO 33.5MM LONG ALTHOUGH IT SHOULD BE 35MM LONG. THERE WAS NO MORE SPARE SCREW OF THE SAME SIZE AND 40MM SCREW WAS AVAILABLE HOWEVER IT WAS TOO LONG FOR THE PT'S BONE. THEREFORE, THE SURGEON USED THE SCREW SECONDLY PICKED (CAT#1890-5053S, LOT#K397907). AFTER THE SURGERY, THE SALES REP. MEASURED THE SCREW AND HE FOUND THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW, FULLY THREADED 5X35 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K422349 K397907

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other