BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT SCREWDRIVER BLADE FOR 01-08050

    MDR report key: 3200199 · Received July 1, 2013

    Report

    Report Number
    0008010177-2013-00137
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 23, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICAL INVESTIGATION REVEALED THAT BOTH WINGS AT THE TIP/WORKING AREA WERE BROKEN. FURTHERMORE, THE FRACTURED SURFACE SHOWED THE APPEARANCE OF A FORCED RUPTURE RESULTING FROM TORSIONAL OVERLOAD. ADDITIONALLY, PRESSURE MARKS WERE SEEN AT THE SLOT AREA FOR BLADE FIXATION AND AT THE HEXAGON AREA INDICATING HIGH BENDING FORCES. THE ROOT CAUSE FOR THE REPORTED EVENT CAN BE ATTRIBUTED TO A USER RELATED HANDLING ISSUE. NO INDICATIONS WERE FOUND FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SURGEON WAS UNABLE TO GET PURCHASE ON THE SCREW. THE CUSTOMER ALSO REPORTED THAT IT BECAME WORSE AS THE SURGEON TRIED. THEY WERE ABLE TO COMPLETE THE PROCEDURE AS THEY HAD ANOTHER DEVICE TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299165 REPLACEMENT SCREWDRIVER BLADE FOR 01-08050 INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-FREIBURG Z7

    Patients

    Seq Age Sex Outcome Treatment
    1