BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°

    MDR report key: 3931094 · Received July 14, 2014

    Report

    Report Number
    0009610622-2014-00324
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: EVALUATION REVEALED THE TROCHANTERIC GAMMA NAIL TO BE THE PRIMARY PRODUCT. ALL OTHER MENTIONED PRODUCTS ARE REGARDED TO BE CONCOMITANT ITEMS. THE RETURNED DEVICE MATCHED THE REPORT, AND THE INCIDENT WAS CONFIRMED. INVESTIGATION REVEALED NO DISCREPANCIES IN MATERIAL AND MANUFACTURING. BASED ON THE ABOVE OBSERVATIONS THE ROOT CAUSE OF THE REPORTED EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICE, BUT CONTRIBUTED BY INTRA-OPERATIVELY DAMAGE OF THE NAIL CAUSED BY A DEVIATED LAG SCREW STEP DRILL (NOTCHING EFFECT/CREATION OF THE STARTING POINT OF THE IMPLANT BREAKAGE AT THE LATERAL EDGE OF THE LEFT BRIDGE). A MORE PRECISE STATEMENT IS NOT POSSIBLE WITH THE INFORMATION GIVEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 11X180 125 DEGREE GAMMA NAIL BROKE. IMPLANT WAS REMOVED AND A 11X360 125 DEGREE GAMMA NAIL WAS IMPLANTED. PATIENT'S ORIGINAL PROCEDURE WAS DONE AT UNKNOWN HOSPITAL IN MICHIGAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 11X180 125 DEGREE GAMMA NAIL BROKE. IMPLANT WAS REMOVED AND A 11X360 125 DEGREE GAMMA NAIL WAS IMPLANTED. PATIENT'S ORIGINAL PROCEDURE WAS DONE AT UNKNOWN HOSPITAL IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410629 TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K0CE024

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention