BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, STST GAMMA3 Ø11X180MM X 130°

    MDR report key: 3200834 · Received July 2, 2013

    Report

    Report Number
    0009610622-2013-00366
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 12, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED. THE NAIL KIT WAS CLASSIFIED AS PRIMARY PRODUCT DURING INVESTIGATION. ALL OTHER RETURNED IMPLANTS ARE ASSOCIATED PRODUCTS AND WILL BE NOT CONSIDERED IN THE INVESTIGATION SUMMERY. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE NAIL KIT RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE INVESTIGATION REVEALED THAT THE NAIL WAS DRILL MARKED WITHIN THE LEFT BRIDGE OF THE PROXIMAL LAG SCREW HOLE. THE LEFT BREAKAGE LINE WAS FOUND WITHIN THE DRILL MARKED AREA. THIS MISDRILLING EFFECT DID WEAK THE LEFT BRIDGE AND CAUSED A NOTCHING EFFECT ON THE LATERAL SIDE, THAT MOST LIKELY FAVOUR SIGNIFICANT THE NAIL BREAKAGE. MISDRILLING COULD OCCUR IN CASE THE TARGET DEVICE WAS PRE-DAMAGED OR INSTRUMENTS WERE NOT ASSEMBLED CORRECTLY; THE OPERATIVE TECHNIQUE INCLUDES THAT THE TARGET DEVICE SHALL BE CHECKED PRIOR TO EVERY SURGERY. LINES OF REST ARE VISIBLE ON BOTH BRIDGES; THE BRIDGES BROKE STEP BY STEP. THE LINES OF REST RUN FROM LATERAL TO MEDIAL. THESE LINES OF REST INDICATE THAT THE NAIL BROKE DUE TO A FATIGUE FRACTURE. MOST LIKELY THE DRILL MARKS DID CONTRIBUTE TO THE BREAKAGE. THE DEEP MATERIAL DEFORMATION AND BEARING POINTS WITHIN THE PROXIMAL NAIL HOLE ON MEDIAL (CAUSED BY THE LAG SCREW) AND THE DEFORMATION OF THE DISTAL NAIL HOLE AND LOCKING SCREW THREAD INDICATE THAT THE IMPLANTS WERE HEAVY LOADED SEVERAL TIMES WITH STRONG AXIAL FORCES MOST LIKELY CAUSED BY FULL WEIGHT BEARING, OBESITY OR INSUFFICIENT PATIENT MOBILIZATION. THESE STRONG AXIAL FORCES DID CONTRIBUTE TO THE NAIL BREAKAGE. THE IFU INCLUDES THAT INTRA-OPERATIVELY IMPLANT DAMAGES SHALL BE AVOIDED AND THAT THE USER MUST BE FAMILIAR WITH THE SYSTEM. FURTHERMORE SEVERAL WARNINGS, CONTRAINDICATIONS AND ADVERSE EFFECTS ARE INCLUDED (LIKE PATIENT MOBILIZATION AND OBESITY). A MORE PRECISE STATEMENT WAS NOT POSSIBLE DUE TO MISSING INFORMATION. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO PREVIOUS OR ACTUAL 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

    THE PRACTICAL NURSE, HAS REPORTED THE FOLLOWING EVENT: "THE NAIL HAS BROKEN AT THE CEPHALIC SCREW. REVISION SURGERY WAS NECESSARY TO REMOVE IT."

    Description of Event or Problem · 1

    THE PRACTICAL NURSE, HAS REPORTED THE FOLLOWING EVENT :"THE NAIL HAS BROKEN AT THE CEPHALIC SCREW. REVISION SURGERY WAS NECESSARY TO REMOVE IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303325 TROCHANTERIC NAIL KIT, STST GAMMA3 Ø11X180MM X 130° IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K289592

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention