BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE PARALLEL BALL JOINT ORIGINAL HOFFMAN

    MDR report key: 2881019 · Received November 12, 2012

    Report

    Report Number
    8031020-2012-00273
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    KTT
    PMA / PMN Number
    K910483
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHILE PERFORMING A STANDING ANKLE SURGERY (TRAUMA SURGERY) ON (B)(6) 2012, THE SURGEON WAS USING A CLAMP AND ONE OF THE BLOTS BROKE WHEN HE WAS TIGHTENING THE BLOT WITH THE BLUE HOFFMAN T HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE PARALLEL BALL JOINT ORIGINAL HOFFMAN IMPLANT KTT STRYKER OSTEOSYNTHESIS SELZACH NA X31422

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other