BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR HANDLE OMEGA2 HANSSON TWIN HOOK

    MDR report key: 2144062 · Received June 1, 2011

    Report

    Report Number
    8031020-2011-00123
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 14, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: (B)(4), LOT K17725, OUTER EXTRACTOR OMEGA2 HANSSON TWIN HOOK; (B)(4), LOT K17925, INNER EXTRACTOR OMEGA2 HANSSON TWIN HOOK; (B)(4), LOT K16367, INNER INTRODUCER; (B)(4), LOT K17928, OUTER INTRODUCER OMEGA PLUS TI.

    Description of Event or Problem · 1

    THE PT UNDERWENT EXTRACTION SURGERY OF THE TWIN HOOK. FIRST, THE SURGEON TRIED TO COMBINE THE INNER EXTRACTOR AND THE EXTRACTOR HANDLE AND TO REMOVE THE TWIN HOOK. HOWEVER, HOOK OF TWIN HOOK WAS NOT ABLE TO BE RETURNED. NEXT, THE HOOK WAS NOT ABLE TO BE RETURNED THOUGH THE SURGEON COMBINED AND USED THE OUTER INTRODUCER AND EXTRACTOR HANDLE. AFTERWARDS, THE TIP OF EXTRACTOR HANDLE BROKE WHEN THE SURGEON WAS ABOUT TO COMBINE THE INNER EXTRACTOR, OUTER EXTRACTOR, AND EXTRACTOR HANDLE AND TO RETURN HOOK. THEREFORE, THE SURGEON PULLED OUT THE HOOK GRIPPING THE END OF HOOK WITH PLIERS. THE SURGEON IS REQUESTING THE INVESTIGATION OF STRENGTH OF THE EXTRACTOR HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR HANDLE OMEGA2 HANSSON TWIN HOOK INSTRUMENT LXH STRYKER OSTEOSYNTHESIS SELZACH NA K16371

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other