BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT-HANDLE F/ETN RADIOLUC SHORT

    MDR report key: 4122011 · Received September 26, 2014

    Report

    Report Number
    3003875359-2014-10291
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 2, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. THE INVESTIGATION COULD NOT BE COMPLETED; 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.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE INVESTIGATION OF THE COMPLAINT INSERT HANDLE SHOWS THAT THE THREAD USED OR FIXATION OF THE EXTENSION BREAK OUT. THE INSERT HANDLE PRODUCED IN 2009 SHOWS REGULAR MARKS OF USE. FURTHER INVESTIGATION OF DOCUMENTATION FOR MATERIAL AND MANUFACTURING SHOWS THAT THE INSTRUMENTS PRINT SPECIFICATION. NO FAULT IN MATERIAL OR MANUFACTURING COULD BE DETECTED. AFTERWARDS AND WITHOUT ADDITIONAL DETAILS IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE DAMAGE. MECHANICAL OVERLOAD LEAD INTO A FATIGUE CRACK OF THE MATERIAL. 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 THREAD IN INSERTION HANDLE BROKE. THERE WERE NO REPORTS OF AN SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR COMPLAINT COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600985 INSERT-HANDLE F/ETN RADIOLUC SHORT MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 3286209

    Patients

    Seq Age Sex Outcome Treatment
    1