BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM F/A2FN

    MDR report key: 3953546 · Received July 23, 2014

    Report

    Report Number
    2520274-2014-12772
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON HAD INSERTED THE EXPERT ASIAN FEMORAL NAIL AND WAS THEN INSERTING THE GUIDE WIRES THROUGH THE AIMING ARM INTO THE FEMORAL FOR THE RECON SCREWS. THE FIRST GUIDE WIRE COMPLETELY MISSED THE NAIL LOOKING LIKE THE WIRE HAD HIT THE NAIL AND BOUNCED OF POSTERIORLY AND SUPERIOR. IT WAS ENSURED THE AIMING ARM AND JIG WERE TIGHTENED AND TRIED AGAIN; THE SAME THING HAPPENED. THE SURGEON THEN TRIED PUTTING THE WIRE IN THE INFERIOR RECON SCREW HOLE WHICH LINED UP AND WENT THROUGH THE CORRECT HOLE INTO THE FEMORAL HEAD. BY HAVING THE INFERIOR HOLE IN POSITION AND SECURED BY A GUIDE WIRE IT THEN ENSURED THE SUPERIOR SCREW LINED UP THROUGH THE JIG AS WELL. THERE WAS NO DELAY IN SURGERY AND NO PATIENT HARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430599 AIM-ARM F/A2FN MISC ORTHO SURGICAL INSTR LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1