BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MM GUIDE WIRE 400MM

    MDR report key: 2885146 · Received December 26, 2012

    Report

    Report Number
    2520274-2012-04293
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Date of Event
    November 25, 2012
    Report Date
    November 25, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    DURING A TFN PROCEDURE, THE HELICAL BLADE WOULD NOT ADVANCE THROUGH THE HOLE IN THE NAIL. THE LOCKING MECHANISM WAS NOT DEPLOYED, AND WAS IN THE CORRECT POSITION. THE HELICAL BLADE WAS HITTING AGAINST THE DISTAL PART OF THE SCREW HOLE. THE SURGEON THEN REALIZED THAT THE GUIDE WIRE WAS OFF-CENTER. THE SURGEON REMOVED THE GUIDE WIRE AND HELICAL BLADE, AND TIGHTENED BLADE GUIDE SLEEVE ASSEMBLY. SURGEON THEN REPOSITIONED THE GUIDE WIRE TO THE CENTER OF THE HOLE. THE SURGEON WAS ABLE TO IMPLANT A SHORTER HELICAL BLADE IN THE SAME NAIL WITH NO FURTHER PROBLEM, AND NO HARM TO THE PATIENT. THIS IS 3 OF 3 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.2MM GUIDE WIRE 400MM GUIDE WIRE LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR HELICAL BLADE, NAIL