BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREWDRIVER GAMMA3 380X110MM

    MDR report key: 3200835 · Received July 2, 2013

    Report

    Report Number
    0009610622-2013-00363
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 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

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED. EVALUATION REVEALED THE LAG 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. 3 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 DEFORMED AND DAMAGED PEGS AND INNER ROD THREAD ARE A RESULT OF AN INADEQUATE USAGE AND TOO HIGH TORSION FORCES DURING LAG SCREW INSERTION OR EXTRACTION. A PRE-DAMAGING OF THE INSTRUMENTS IN PRIOR SURGERIES COULD NOT BE EXCLUDED. THE NEEDED TORSION FORCE TO INSERT A LAG SCREW WITH THE SCREWDRIVER IS REVEALED IN THE DHF (APPROX. 7NM) AND AN INTERNAL LAB TEST CONFIRMED THAT THIS NEEDED FORCE IS DEFINITELY REACHED (<40NM, LAB TEST# (B)(4)). FURTHERMORE ADDITIONAL METHODS ARE AVAILABLE TO EXTRACT THE LAG SCREW WITHOUT THE LAG SCREWDRIVER. THE METHODS ARE DESCRIBED IN BROCHURE# (B)(4), ¿EXTRACTION SET.¿ NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO ACTIONS ARE IN PLACE.

    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 THE WIRE PORTION OF INSERTER BENT UPON INSERTION WHEN DOCTOR TRIED TO TAKE OUT THE LAG SCREW. REP HAD A BACK UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WIRE PORTION OF INSERTER BENT UPON INSERTION WHEN DOCTOR TRIED TO TAKE OUT THE LAG SCREW. REP HAD A BACK UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303334 LAG SCREWDRIVER GAMMA3 380X110MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K132913

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other