BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.0MM/4.0MM DRILL SLEEVE 164MM

    MDR report key: 3000261 · Received March 12, 2013

    Report

    Report Number
    8030965-2013-10484
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 1, 2012
    Report Date
    February 1, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED THE INSERTION HANDLE WAS ASSEMBLED TO THE AIMING ARM. USING THE PROTECTION SLEEVE, DRILL SLEEVE AND TROCAR IT WAS FOUND THAT THERE IS PROPER ALIGNMENT FROM THE INSERTION HANDLE TO THE NAIL SCREW HOLE. THE COMPLAINT CONDITION CANNOT BE REPLICATED. IT IS CONCLUDED THAT THIS COMPLAINT IS INVALID BASED ON THE INABILITY TO REPLICATE THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON TRIED TO LOCK THE SCREW DISTALLY THROUGH THE AIMING ARM FOR A RIGHT HIP/FEMUR FRACTURE, THE SCREW DID NOT GO THROUGH THE NAIL - IT MISSED THE NAIL. SURGEON PERFORMED A FREE HAND INSERTION OF THE SCREW INTO THE NAIL. ONE OR MORE OF THE DEVICES THAT CREATE THE INSTRUMENTATION CONSTRUCT MAY HAVE CAUSED MISALIGNMENT. THIS IS REPORT 3 OF 4 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103599 8.0MM/4.0MM DRILL SLEEVE 164MM FZX SYNTHES GMBH 7629102

    Patients

    Seq Age Sex Outcome Treatment
    1