BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°

    MDR report key: 4220584 · Received November 3, 2014

    Report

    Report Number
    0009610622-2014-00617
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 25, 2014
    Report Date
    October 6, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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

    THE 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 TO 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 FULLY BROKEN, THE POSTERIOR BRIDGE FOLLOWED ALSO STEP BY STEP (FATIGUE FRACTURE). FINALLY THE POSTERIOR BRIDGE BROKE SPONTANEOUS IN A FORCED BRITTLE FRACTURE TOWARDS POSTERIOR. BEARING POINTS ON THE DISTAL PART OF THE PROXIMAL NAIL HOLE INDICATE THAT LOADS WERE APPLIED POSTOPERATIVELY TO THE IMPLANTS; THESE LOADS DID MOST LIKELY ALSO CONTRIBUTE TO THE NAIL BREAKAGE. INTRA-OPERATIVELY IMPLANT DAMAGES AND POSTOPERATIVELY LOADS ARE LISTED AS ADVERSE EFFECTS IN THE IFU. IF OTHER LISTED ADVERSE EFFECTS LIKE POOR BONE QUALITY OR POOR BONE CONSOLIDATION DID ALSO CONTRIBUTE TO THE NAIL BREAKAGE CANNOT BE EXCLUDED. NO MANUFACTURER RELATED ISSUES WERE FOUND; THEREFORE 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 SURGEON, THAT THE NAIL IS FRACTURED. THE NAIL WAS IMPLANTED (B)(6) 2014 AND REVISED ON (B)(6) 2014. PATIENT BEGUN TO PROGRESSIVELY WALK WITH ASSISTANCE. HE HAD PROGRESSIVE PAIN WHEN WALKING. NO FALL OR TRAUMA.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE SURGEON, THAT THE NAIL IS FRACTURED. THE NAIL WAS IMPLANTED (B)(6) 2014 AND REVISED ON (B)(6) 2014. PATIENT BEGUN TO PROGRESSIVELY WALK WITH ASSISTANCE. HE HAD PROGRESSIVE PAIN WHEN WALKING. NO FALL OR TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702690 TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K0629A9

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention