BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø10X360MM X 125°

    MDR report key: 3141327 · Received June 3, 2013

    Report

    Report Number
    0009610622-2013-00308
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 13, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 INCIDENT WAS CONFIRMED. INVESTIGATION REVEALED NO DISCREPANCIES IN MATERIAL OF MANUFACTURING. ACCORDING TO THE DAMAGE AND THE EVIDENCES OF THE BREAKAGE SURFACES THE NAIL BROKE IN A FATIGUE FRACTURE DUE TO OVERLOAD, CONTRIBUTED BY INTRA OPERATIVELY DAMAGE OF THE NAIL CAUSED BY A DEVIATED LAG SCREW STEP DRILL. DUE TO A NOTCHING EFFECT, THE MISS DRILLING MOST LIKELY HAD CREATED THE STARTING POINT OF THE IMPLANT BREAKAGE AT THE LATERAL EDGE OF THE ANTERIOR BRIDGE. WE DID NOT RECEIVE A REASONABLE STATEMENT REGARDING POSTOPERATIVE MOBILIZATION INSTRUCTIONS / WEIGHT BEARING. NEVERTHELESS, AS THE PATIENT WAS REVISED IT CAN BE ASSUMED THAT BONE CONSOLIDATION WAS INSUFFICIENT. CONSEQUENTLY, THE NAIL WAS NOT RELIEVED BY BONE CONSOLIDATION AND HAD TO ABSORB THE COMPLETE LOAD APPLICATION DURING THE IMPLANTATION PERIOD. INCREASING AND / OR PERMANENT LOAD APPLICATION WILL INEVITABLY LEAD TO FATIGUE OF MATERIAL. EVALUATION REVEALED EVIDENCE THAT THE EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICE BUT IS RATHER RELATED TO HIGH LOAD APPLICATION BY THE PATIENT CONTRIBUTED BY INTRA OPERATIVE DAMAGE OF THE PROXIMAL DRILL HOLE. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE AND LEVEL 1 ROOT CAUSE INDICATED THE ISSUE WAS WITHIN TOLERANCE, THEREFORE, NO CORRECTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    GAMMA NAIL BROKE IN PATIENT.

    Description of Event or Problem · 1

    GAMMA NAIL BROKE IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245052 LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø10X360MM X 125° IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K900066

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention