BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM F/AFN

    MDR report key: 3672654 · Received March 11, 2014

    Report

    Report Number
    3003875359-2014-10012
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    February 14, 2014
    Report Date
    February 14, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE RETURNED AIMING ARM AND INSERTION HANDLE (357.521 & 357.522) DO NOT SHOW ANY VISUAL SIGNS OF DAMAGE OR IMPAIRMENT. ONLY THE KNURLED SCREW HEAD HAD A DEEP MARK. WITH THE RETURNED DEVICE, THE DESCRIBED COMPLAINT STATE COULD NOT BE REPLICATED. FUNCTIONAL TESTING WITH EQUIVALENT INSTRUMENTATION WAS SUCCESSFUL AND DID NOT SHOW ANY DEVIATION FROM THE INTENDED USE. FIRST, THE AIMING ARM WAS MOUNTED ONTO THE INSERTION HANDLE. THEN AN ANTERIOR FIXATION NAIL WAS MOUNTED TO THE INSERTION HANDLE, AND THE PROTECTION SLEEVE TOGETHER WITH THE DRILL SLEEVE WAS INSERTED INTO THE RETURNED AIMING ARM ACCORDING THE STEPS IN THE USER GUIDE. THEN A 2.8MM GUIDE WIRE WAS INSERTED THROUGH THE DRILL SLEEVE AND THROUGH THE HOLE OF THE NAIL. THE SAME WAS DONE WITH THE 6.5/4.5MM REAMER (WITHOUT DRILL SLEEVE). BOTH, THE GUIDE WIRE AND THE REAMER COULD BE INSERTED INTO THE NAIL. IT WAS NOT POSSIBLE TO FAIL THE HOLE WITH THE GUIDE WIRE. ALL THESE FINDINGS ARE VALID FOR BOTH RECON POSITIONS. ADDITIONAL OBSERVATIONS: THE CENTERING PINS (512488 & 512489) IN THE AIMING ARM ARE TOGGLING SLIGHTLY. THIS RESULTS INTO A SMALL MOTION FROM THE AIMING ARM RELATIVE TO THE INSERTION HANDLE IF THE KNURLED SCREW IS NOT TIGHTENED STRONGLY. THIS COULD EXPLAIN THE DEEP MARK ON THE SCREW HEAD. MOREOVER THERE IS A PLAY BETWEEN THE PROTECTIVE SLEEVE AND THE AIMING ARM. THERE IS ALSO PLAY BETWEEN THE PROTECTIVE SLEEVE AND THE AIMING ARM FROM THE DEMO MATERIAL, BUT MUCH LESS. BUT STILL WITH THESE FACTS, THE COMPLAINT COULD NOT BE REPLICATED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/ EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A NAIL INSERTION THE RECON GUIDE WIRES STRUCK THE NAIL AND WERE NOT ABLE TO BE INSERTED. THE SURGEON MADE MULTIPLE ATTEMPTS AT MANUALLY MANIPULATING THE AIMING ARM TO REDIRECT THE COURSE OF THE GUIDE WIRES THROUGH THE NAIL. SURGERY WAS DELAYED FOR 30 MINUTES AND COMPLETED SUCCESSFULLY WITH NO PATIENT HARM REPORTED. THIS IS REPORT 2 OF 2 FOR COMPLAINT COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144718 AIM-ARM F/AFN GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES HAGENDORF 2077007

    Patients

    Seq Age Sex Outcome Treatment
    1