BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANSSON PIN TI 100MM

    MDR report key: 3844595 · Received June 3, 2014

    Report

    Report Number
    0008031020-2014-00266
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HTY
    PMA / PMN Number
    K033968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BASED ON THE RECEIVED X-RAYS THE REPORTED EVENT OF THE HOOK BACKED OUT COULD BE CONFIRMED. THE COMPLAINT HISTORY WAS REVIEWED AND SIMILAR EVENTS REVEALED THAT THERE IS ENOUGH LENGTH OF THE HOOK REMAINING EXTRUDED IN THE FEMORAL HEAD TO GIVE SUFFICIENT SUPPORT AGAINST BACKING OUT OF THE PIN SYSTEM. SIMILAR EVENTS WERE REVIEWED BY TWO EXPERIENCED TRAUMA SURGEONS. BOTH INDEPENDENTLY STATED THAT SUCH AN EVENT HAS NO IMPACT ON THE PERFORMANCE AND THE SAFETY OF THE DEVICE. THE OUTCOME OF THE PATIENT IS NOT AFFECTED BY SUCH A LITTLE BACK OUT. NO FURTHER ACTION IS REQUIRED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. NO EVALUATION WILL BE PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT THE SURGERY WITH THE HANSSON PIN SYSTEM. ON (B)(6) 2014, THE SURGEON FOUND THAT THE HOOK WAS BACKED OUT (ABOUT 2MM). THE SURGEON IS MONITORING THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT THE SURGERY WITH THE HANSSON PIN SYSTEM. ON (B)(6) 2014, THE SURGEON FOUND THAT THE HOOK WAS BACKED OUT (ABOUT 2MM). THE SURGEON IS MONITORING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323511 HANSSON PIN TI 100MM PIN, FIXATION, SMOOTH HTY STRYKER TRAUMA SELZACH T128338

    Patients

    Seq Age Sex Outcome Treatment
    1 Other