BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 4093802 · Received September 16, 2014

    Report

    Report Number
    3003875359-2014-10271
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BIT FOR DISTAL LOCKING DID NOT PASS THROUGH THE CANNULATION OF THE NAIL INSTEAD IT STRUCK THE NAIL. THE SURGEON HAD TO REMOVE THE AIMING ARM AND PERFORM FREEHAND LOCKING. THERE WERE NO REPORTS OF A SURGICAL DELAY OR PATIENT HARM. THIS REPORT IS 5 OF 6 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THERE WAS A FIFTEEN MINUTE DELAY IN THE PROCEDURE. THE INSTRUMENTS WERE INSPECTED BY SYNTHES ON SITE DIRECTLY AFTER THE EVENT AND TESTED ON A DEMO NAIL. ALL INSTRUMENTS SEEMED TO FUNCTION CORRECTLY. IT WAS CONFIRMED THAT THE CORRECT OPTION ON THE AIMING ARM WAS CHOSEN (I.E.240MM NAIL OPTION) AND THAT ALL CONNECTION SCREWS WERE FASTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573247 RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 8365828

    Patients

    Seq Age Sex Outcome Treatment
    1