BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER, LONG T2 TIBIA 3,5 MM

    MDR report key: 3230947 · Received July 17, 2013

    Report

    Report Number
    0009610622-2013-00396
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 23, 2013
    Report Date
    June 24, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION: THE REPORTED ISSUE WAS CONFIRMED. EVALUATION REVEALED THE SCREWDRIVER TO BE THE PRIMARY PRODUCT. NO ASSOCIATED PRODUCTS WERE REPORTED. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICE HAD BEEN IN USE FOR APPROX. 1.5 YEARS WE PRE-SUPPOSE THAT IT HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE BREAKAGE SURFACE INDICATES THAT THE SCREWDRIVER TIP BROKE DUE TO A TORSION OVERLOAD DURING INSERTION OF THE END CAP. A PRE-DAMAGE IS POSSIBLE. BECAUSE NO FAILURES WERE FOUND IN THE MATERIAL, DIMENSIONS OR DHR A MANUFACTURING ISSUE COULD BE EXCLUDED; THEREFORE THE ISSUE IS ATTRIBUTED TO A ROUGH HANDLING BY THE USER. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO ACTIONS ARE IN PLACE.

    Description of Event or Problem · 1

    THE TIP OF THE 3.5 HEX SCREWDRIVER BROKE OFF WHILE INSERTING THE STANDARD END CAP FOR THE SCN.

    Description of Event or Problem · 1

    THE TIP OF THE 3.5 HEX SCREWDRIVER BROKE OFF WHILE INSERTING THE STANDARD END CAP FOR THE SCN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330831 SCREWDRIVER, LONG T2 TIBIA 3,5 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K288905

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other