BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3852598 · Received June 6, 2014

    Report

    Report Number
    0009610622-2014-00264
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034343
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED DEVICES MATCHED THE REPORT AND THE NAIL BREAKAGE WAS CONFIRMED. FAILURES IN MATERIAL OR MANUFACTURING OF THE AFFECTED NAIL RETURNED WERE NOT FOUND. DIMENSIONAL EXAMINATION REVEALED NO DEVIATIONS IN THE RELEVANT UNDAMAGED AREAS OF THE NAIL RETURNED. THE AFFECTED ITEM REPORTED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. THUS, WE EXCLUDE DEVIATIONS IN MATERIAL AND MANUFACTURING. ACCORDING TO THE DAMAGE AND THE EVIDENCES OF THE BREAKAGE SURFACES, THE NAIL BROKE IN A FATIGUE FRACTURE DUE TO AXIAL OVERLOAD AFTER AN IMPLANTATION PERIOD OF 4 MONTHS. ACCORDING TO THE MEDICAL RECORDS RECEIVED THE SURGEON STATED ON (B)(6) 2014: ¿(¿) INCREASING VARUS DEFORMITY OF THE PATHOLOGIC FRACTURE, NO SIGNS OF BONE CONSOLIDATION.¿ FURTHER, HE DIAGNOSED ¿SUBTROCHANTERIC METASTASIS FEMUR¿. THE INFORMATION RECEIVED AND THE X-RAYS WERE FORWARDED TO A HCP FOR REVIEW. HE COMMENTED AMONG OTHERS: ¿IN THIS CASE BONE HEALING WAS NOT TO BE EXPECTED. (¿) IF EXPECTED BONE HEALING DOES NOT TAKE PLACE (AS EVIDENTLY IN THIS CASE) THERE IS AN INCREASED RISK THAT A FATIGUE FRACTURE OF THE GAMMA NAIL OCCURS DUE TO PROLONGED OVERLOAD BY THE PATIENT; THE NAIL CAN NO LONGER FULFILL ITS FUNCTION FOR BRIDGING AND INTERNAL SPLINTING OF THE FRACTURE. IN ADDITION TO THE CONSEQUENCES OF THE FALL THE PATIENT SUFFERED FROM A PATHOLOGIC SUBTROCHANTERIC FEMORAL FRACTURE. THEREFORE, THE MAIN REASON FOR THIS OCCURRING FRACTURE WAS LESS AN ADEQUATE ACCIDENT BUT RATHER A PROGRESSIVE DESTRUCTION AND WEAKENING OF THE BONE BY A METASTASIS OF A RENAL CELL CARCINOMA. IN CASE OF SUCH PATHOLOGICAL FRACTURE NORMAL BONE HEALING IS VERY UNLIKELY, EVEN WITH OPTIMAL SURGICAL TREATMENT (E.G. WITH A GAMMA NAIL). BASED ON THE ABOVE THE NAIL BREAKAGE IS NOT LINKED TO A DEFICIENCY OF THE DEVICE, BUT IS RATHER CONSIDERED PATIENT RELATED (INSUFFICIENT BONE HEALING / NON-UNION CONTRIBUTED BY HIGH AXIAL LOAD) AFTER AN IMPLANTATION PERIOD OF 4 MONTHS).

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ASSISTANCE SURGEON THAT THEY HAD A REVISION SURGERY DUE TO A BROKEN GAMMA NAIL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ASSISTANCE SURGEON THAT THEY HAD A REVISION SURGERY DUE TO A BROKEN GAMMA NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332040 LONG NAIL KIT R2.0, STST, RIGHT GAMMA3® Ø11X340MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K029DB5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention