BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEARDROP HANDLE, AO COUPLING CANNULATED

    MDR report key: 1837789 · Received September 14, 2010

    Report

    Report Number
    9610622-2010-00372
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 24, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: A HARDNESS TEST ACCORDING TO ROCKWELL, REVEALED THE HARDNESS OF THE MATERIAL BEING WITHIN SPECIFIED PARAMETERS. REVIEW OF DEVICE HISTORY RECORD (DHR) - A REVIEW OF THE DHR FOR THE TEARDROP HANDLE (LOT CODE K433880) REVEALED NO DISCREPANCIES. DISCREPANCIES IN MFG OR MATERIAL WERE NOT FOUND. APPEARANCE OF THE DAMAGE ON THE HEAD OF THE HANDLE REVEALED NON INTENDED USE BUT IT COULD NOT BE EXCLUDED THAT THE INTERFACE DOES NOT MATCH THE REQUIREMENTS TO TRANSFER LOAD WHICH IS NECESSARY FOR INTENDED USE OF THE SCREWDRIVER. INVESTIGATION REVEALED THAT THE REPORTED EVENT IS PRIMARY USER RELATED (ROUGH HANDLING) CONTRIBUTED BY THE DESIGN OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO OUR STRATEGIC SALES EMPLOYEE, THAT THE UPPER PART OF THE SCREWDRIVER WAS NOT REMOVABLE FROM THE HAND GRIP. FURTHER, IT WAS REPORTED THAT THERE WAS A REPLACEMENT PRODUCT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEARDROP HANDLE, AO COUPLING CANNULATED INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K433880

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other