BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø10X260MM X 125°

    MDR report key: 3123687 · Received May 22, 2013

    Report

    Report Number
    0009610622-2013-00278
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 SUMMARY: THE RETURNED DEVICE MATCHED THE REPORT, AND THE EVENT WAS CONFIRMED. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS WITHIN TOLERANCE, THEREFORE NO CORRECTIVE ACTIONS WERE DEEMED NECESSARY AT THIS TIME. NO MATERIAL OR MANUFACTURING FAULTS FOUND. THE RECEIVED NAIL WAS COMPLETELY BROKEN IN THE BRIDGES OF THE PROXIMAL DRILL HOLE FOR THE LAG SCREW. FROM TECHNICAL POINT OF VIEW THE NAIL BROKE IN A FATIGUE FRACTURE ¿ INDICATED BY LINES OF REST AND MISSING PLASTIC DEFORMATION ¿ AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 6 MONTHS. THE INITIAL CRACK WAS ORIGINATED IN AN AREA OF THE BRIDGES WERE MATERIAL DAMAGE HAD OCCURRED INTRA-OPERATIVELY. USUAL AXIAL AND TORSIONAL LOAD APPLICATION DURING THE IMPLANTATION PERIOD MAY HAVE CONTRIBUTED TO THE PROGRESS OF THE CRACK. THE BREAKAGE STARTED MOST LIKELY WITH AN INCIPIENT CRACK IN THE ANTERIOR BRIDGE AT LATERAL WHERE (INTRA-OPERATIVELY CAUSED) DAMAGES HAD LED TO A SHARP EDGE. SHARP EDGES CAUSE ADDITIONAL AND NOT INTENDED NOTCH EFFECTS. EVALUATION REVEALED EVIDENCE THAT THE EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICE BUT IS RATHER RELATED TO OVERLOADING BY THE PATIENT CONTRIBUTED BY ALLEGED NON-UNION AND INTRA-OPERATIVE DAMAGE OF THE NAIL BY A DEVIATED STEP DRILL. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED.

    Description of Event or Problem · 1

    THE PATIENT HAD A GAMMA 3 NAIL IMPLANTED ON 2012 (B)(6). PATIENT WAS FOUND TO BE NONUNION AND THE NAIL WAS BROKEN. PATIENT WAS REVISED ON 2013 (B)(6).

    Description of Event or Problem · 1

    THE PATIENT HAD A GAMMA 3 NAIL IMPLANTED ON (B)(6) 2012. PATIENT WAS FOUND TO BE NONUNION AND THE NAIL WAS BROKEN. PATIENT WAS REVISED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226222 LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø10X260MM X 125° IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K658307

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention