BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X340MM X 125°

    MDR report key: 3982410 · Received August 6, 2014

    Report

    Report Number
    0009610622-2014-00389
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 10, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    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 SUMMARY: THE REPORTED ISSUE WAS CONFIRMED. THE BROKEN NAIL WAS CLASSIFIED AS PRIMARY PRODUCT DURING INVESTIGATION. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE NAIL RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE NAIL WAS DRILL MARKED WITHIN THE ANTERIOR BRIDGE OF THE PROXIMAL LAG SCREW HOLE. THE ANTERIOR BREAKAGE LINE WAS FOUND WITHIN THE DRILL MARKED AREA. THIS MISDRILLING EFFECT DID WEAK THE ANTERIOR BRIDGE AND CAUSED MOST LIKELY A NOTCHING EFFECT ON THE LATERAL SIDE, THAT FAVOURS SIGNIFICANT THE NAIL BREAKAGE. MISDRILLING COULD OCCUR IN CASE THE TARGET DEVICE WAS PRE-DAMAGED, INSTRUMENTS WERE NOT ASSEMBLED CORRECTLY OR BENDING FORCES WERE APPLIED TO THE DRILL AND/OR TARGET DEVICE DURING DRILLING. THE OPERATIVE TECHNIQUE INCLUDES THAT THE TARGET DEVICE SHALL BE CHECKED PRIOR TO EVERY SURGERY. SMOOTH LINES OF REST ARE VISIBLE ON THE ANTERIOR BRIDGE BREAKAGE SURFACE; THE BRIDGE BROKE STEP BY STEP (FATIGUE FRACTURE). THE LINES OF REST RUN FROM LATERAL TOWARDS MEDIAL. THESE LINES OF REST INDICATE (IN COMBINATION WITH THE FOUND DRILL MARKS), THAT THE NAIL BREAKAGE STARTED AT THE ANTERIOR BRIDGE AT LATERAL. AFTER THE ANTERIOR BRIDGE WAS FULL OR MAIN PARTLY BROKEN, THE POSTERIOR BRIDGE FOLLOWED ALSO FIRST STEP BY STEP (FATIGUE FRACTURE) AND FINALLY SPONTANEOUS TO POSTERIOR IN A BRITTLE FRACTURE. BEARING POINTS ON THE DISTAL PART OF THE PROXIMAL NAIL HOLE INDICATE THAT HEAVY LOADS WERE APPLIED POSTOPERATIVELY TO THE IMPLANTS. THE CUSTOMER REPORTED THAT A PSEUDOARTHROSIS WAS DETECTED, MEANS THE BONE FRACTURE WAS NOT HEALED (NON-UNION). NON-UNIONS, POSTOPERATIVELY LOADS AND INTRA-OPERATIVELY IMPLANT DAMAGES ARE LISTED AS ADVERSE EFFECTS IN THE IFU AND CAN LEAD TO IMPLANT BREAKAGES. BASED ON THE GIVEN INFORMATION AND THE FACT THAT NO MANUFACTURER RELATED ISSUES WERE FOUND THE CASE IS ATTRIBUTED TO A USER ERROR CONTRIBUTED BY THE PATIENT. NO NON-CONFORMITY IDENTIFIED.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE NURSE THAT A G3 NAIL BROKE.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE NURSE THAT A G3 NAIL BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461515 LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X340MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K07107E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention