BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3 Ø10X170MM X 125°

    MDR report key: 3132204 · Received May 29, 2013

    Report

    Report Number
    0009610622-2013-00284
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 2, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: RECEIVED X-RAYS 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 ARE DEEMED NECESSARY AT THIS TIME. NO DEVIATION WAS FOUND IN THE MANUFACTURING DOCUMENTS. NO DEVIATION IN FUNCTION WAS FOUND. IT WAS CONCLUDED THAT MOST LIKELY THE SET SCREW HAD BEEN UNSCREWED FOR MORE THAN ¼ OF A TURN RESULTING IN EXCEEDED MOTION OF THE LAG SCREW TOWARDS MEDIAL. FROM TECHNICAL POINT OF VIEW IN THIS CASE NO IMPLANT FAILURE WAS VERIFIED. LIMITED MEDICAL INFORMATION SUGGESTED A MEDICAL STATEMENT BEING NOT REASONABLE. THE EVENT WAS NOT CAUSED BY A DEFICIENCY OF THE DEVICES. THE RETURNED UNITS PERFORMED AS INTENDED. THE CAUSE OF THE EVENT WAS RATHER INSUFFICIENT PLACEMENT OF THE SET SCREW.

    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

    THE PATIENT HAD THE PRIMARY SURGERY OF GAMMA3 ON (B)(6) 2013. THE PATIENT COMPLAINED THE PAIN AT HIP AND FOUND THAT RUG SCREW PENETRATED THE HEAD OF HIP TO THE PELVIS ON XRAYS ON (B)(6) 2013. ON (B)(6) 2013 THE DEVICES WERE REMOVED FROM THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT HAD THE PRIMARY SURGERY OF GAMMA3 ON 2013 (B)(6). THE PATIENT COMPLAINED THE PAIN AT HIP AND FOUND THAT RUG SCREW PENETRATED THE HEAD OF HIP TO THE PELVIS ON XRAYS ON 2013 (B)(6). ON 2013 (B)(6) THE DEVICES WERE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235173 TROCHANTERIC NAIL KIT, TI GAMMA3 Ø10X170MM X 125° IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K282435

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention