BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX

    MDR report key: 3020294 · Received March 25, 2013

    Report

    Report Number
    2530088-2013-00407
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Report Date
    March 14, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THIS REPORT IS PART OF THE SERVICE AND REPAIR DOCUMENTATION REMEDIATION. DEVICES THAT WERE RECEIVED BY SERVICE AND REPAIR HAVE EITHER BEEN REPAIRED AND RETURNED TO THE CUSTOMER OR DISCARDED BY SYNTHES, MAKING FURTHER PRODUCT EVALUATION BY MANUFACTURING OR ENGINEERING IMPOSSIBLE. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    SERVICE AND REPAIR REPORT STATES DRILL BIT HITS NAIL IN STATIC MODE, WHICH DAMAGED COMPONENT. DEVICE MALFUNCTIONED DURING SURGERY WHILE BEING USED ON PATIENT. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121677 RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX GUIDE FZX SYNTHES BRANDYWINE 4957589

    Patients

    Seq Age Sex Outcome Treatment
    1