BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCHANTERIC NAIL KIT, STST GAMMA3 Ø11X180MM X 130°

    MDR report key: 3092564 · Received May 3, 2013

    Report

    Report Number
    0009610622-2013-00239
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: MANUFACTURING OR MATERIAL FAULTS WERE NOT FOUND. APPEARANCE OF THREAD FLANKS AND TEXTURE OF SURFACES WITH CLEAR TRACES OF CROSS-THREADING INDICATE THE SET SCREW HAVING BEEN INSERTED UNDER SIGNIFICANT MISALIGNMENT BY IMMENSE FORCE. EVALUATION REVEALED EVIDENCE THAT THE EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICES BUT IS RATHER RELATED TO USE ERROR.

    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 SURGEON, REPORTED TO THE SALES REP, THAT "WHEN PLACING THE GAMMA NAIL, WHEN THE SURGEON WANTED TO PUT THE SET SCREW IN PLACE, HE WAS UNABLE TO FULLY SET THIS SCREW. HE HAD TO REMOVE THE NAIL AND THE LAG SCREW, AND HE HAD TO PLACE ANOTHER NAIL. THERE WAS NO OTHER 130° NAIL AVAILABLE IN THIS HOSPITAL, SO HE HAD TO PUT A 125° NAIL. THE SURGEON SAID THIS WAS SUB OPTIMAL."

    Description of Event or Problem · 1

    THE SURGEON, REPORTED TO THE SALES REP, THAT "WHEN PLACING THE GAMMA NAIL, WHEN THE SURGEON WANTED TO PUT THE SET SCREW IN PLACE, HE WAS UNABLE TO FULLY SET THIS SCREW. HE HAD TO REMOVE THE NAIL AND THE LAG SCREW, AND HE HAD TO PLACE ANOTHER NAIL. THERE WAS NO OTHER 130° NAIL AVAILABLE IN THIS HOSPITAL, SO HE HAD TO PUT A 125° NAIL. THE SURGEON SAID THIS WAS SUB OPTIMAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194946 TROCHANTERIC NAIL KIT, STST GAMMA3 Ø11X180MM X 130° IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K241609

    Patients

    Seq Age Sex Outcome Treatment
    1 Other