BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW AXSOS 4.0MM / L80MM

    MDR report key: 3249069 · Received July 26, 2013

    Report

    Report Number
    0008031020-2013-00248
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    May 31, 2013
    Report Date
    July 3, 2013
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K050512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE SCREW BROKE DURING EXTRACTION OF THE SCREW COULD NOT BE CONFIRMED, SINCE THE SCREW OR PART OF THE SCREW WERE NOT RETURNED, AND NO X-RAYS WERE SUPPLIED, THEREFORE THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE CONFIRMED. BASED ON THE REPORTED EVENT OF THE SCREW BREAKING DURING EXTRACTION, THE OPERATIVE TECHNIQUE FOR INSTRUMENT EXTRACTION WAS REVIEWED. THE OPERATIVE TECHNIQUE INDICATES THAT "[¿] HARDWARE REMOVAL IS ALMOST ALWAYS MORE CHALLENGING THAN THE INSERTION OF THE IMPLANTS. SPECIALTY INSTRUMENTS CAN SIGNIFICANTLY FACILITATE HARDWARE REMOVAL WHILE MINIMIZING DAMAGE TO THE SURROUNDING BONE AND SOFT-TISSUE. [¿] COLD WELDED SCREWS REQUIRE CUTTING TOOLS FOR METAL TO REMOVE THE SCREWS. THE EXTRACTION SET DOES NOT FEATURE CARBIDE DRILLS OR OTHER CUTTING TOOLS TO REMOVE COLD WELDED SCREWS. [¿]" A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. 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 ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE DETERMINED DURING THE INVESTIGATION. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER AT (B)(6), REPORTED THE FOLLOWING EVENT, PATIENT INITIALLY HOSPITALIZED FOR IMPLANTATION OF PLATE AND LOCKING SCREWS IN (B)(6) 2010. CAME BACK TO EXPLANT THE HARDWARE IN (B)(6) 2013. WHILE EXPLANTING THE LOCKING SCREWS, THE SCREWS BROKE. THE THE PLATE COULDN'T BE EXTRACTED. SURGERY WAS INTERRUPTED AND WILL HAVE TO BE RESCHEDULED.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER, REPORTED THE FOLLOWING EVENT, PATIENT INITIALLY HOSPITALIZED FOR IMPLANTATION OF PLATE AND LOCKING SCREWS IN (B)(6) 2010. COME BACK TO EXPLANT THE HARDWARE IN (B)(6) 2013. WHILE EXPLANTING THE LOCKING SCREWS, THE SCREWS BROKE. THE PLATE COULDN'T BE EXTRACTED. SURGERY WAS INTERRUPTED AND WILL HAVE TO BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351309 LOCKING SCREW AXSOS 4.0MM / L80MM IMPLANT HRS STRYKER TRAUMA SELZACH P03970

    Patients

    Seq Age Sex Outcome Treatment
    1 Other