BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDLOCK SLEEVE GAMMA3® 180

    MDR report key: 5746503 · Received June 23, 2016

    Report

    Report Number
    0009610622-2016-00305
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Date of Event
    May 31, 2016
    Report Date
    May 31, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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 REVEALED THE NAIL HOLDING SCREW GAMMA3® 8X35MM TO BE THE SUBJECT PRODUCT. ALL OTHER DEVICES ARE REGARDED TO BE CONCOMITANT PRODUCTS. REVIEW OF THE DEVICE HISTORY RECORDS (NHS AND TARGET DEVICE) REVEALED NO DISCREPANCIES. THE ITEMS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION, AND AS THEY BEEN IN USE FOR APPROX. 5 1/2 YEARS WE PRESUPPOSE THAT THEY HAD FULFILLED THEIR TASKS IN FORMER SURGERY AS INTENDED. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE MATERIAL OF THE NHS RIM IS SEIZED OUTWARDS. CORRESPONDING DAMAGE WAS FOUND ON THE CORRESPONDING AREA OF THE TARGET DEVICE. FURTHERMORE THE RIM IS HEAVILY DAMAGED AND DEFORMED. HITTING MARKS ARE VISIBLE WITHIN THE NHS HEAD. THEREFORE THE NHS WAS HIT DIRECTLY BY A TOOL, MOST LIKELY TO INSERT AN ASSEMBLED NAIL INTO A BONE MARROW CHANNEL. FRETTING IS A RARE BUT KNOWN REACTION IN CASE THE MATERIALS OF THE NHS AND THE NAIL HANDLE COME IN CONTACT WHICH EACH OTHER. DURING SCREWING INTO THE NAIL IT IS POSSIBLE THAT THE NHS GETS IN CONTACT WITH THE INNER SURFACE OF THE NAIL HANDLE TUBE, AND FRICTION OCCURS DUE TO A SUBOPTIMAL (SLIGHT OBLIQUE) AXIAL INSERTION. THE APPEARANCE OF THE DAMAGE INDICATES THAT THE DEVICES GOT JAMMED BY ¿COLD WELDING¿ DUE TO FRICTION CORROSION CAUSED BY HIGH SURFACE PRESSURE. MOST LIKELY HIGH SURFACE PRESSURE GENERATED BY HIGH LOAD APPLIED TO THE NHS HAD LED TO THE FOUND DAMAGES. LOCAL SURFACE PRESSURE MAY ARISE WHEN THE ITEMS ARE ASSEMBLED UNDER MISALIGNMENT (USE ERROR). THE OPERATIVE TECHNIQUE ADVISES UNDER CHAPTER ¿ASSEMBLY OF THE TARGET DEVICE AND THE GAMMA3 NAIL 180¿ IN DETAIL HOW TO ASSEMBLE THE NAIL TO THE TARGET DEVICE WITH THE NAIL HOLDING SCREW. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY CONSPICUITY. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE ARE NO ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT. BASED ON THE ABOVE FINDINGS WE COME TO THE CONCLUSION THAT THE REPORTED EVENT IS NOT DEVICE BUT RELATED TO A USE ERROR. NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE SURGEON AND THE PHARMACIST REPORTED THE FOLLOWING EVENT : " DURING A SURGERY WHICH CONSISTED IN IMPLANTING A LONG NAIL GAMMA, IT WAS NOT POSSIBLE TO UNLOCK THE NAIL FROM THE ANCILLARY"

    Description of Event or Problem · 1

    THE SURGEON AND THE PHARMACIST REPORTED THE FOLLOWING EVENT: "DURING A SURGERY WHICH CONSISTED IN IMPLANTING A LONG NAIL GAMMA, IT WAS NOT POSSIBLE TO UNLOCK THE NAIL FROM THE ANCILLARY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401122 SPEEDLOCK SLEEVE GAMMA3® 180 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL KP306090

    Patients

    Seq Age Sex Outcome Treatment
    1 Other