BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM STARDRIVE SCREWDRIVER SHAFT

    MDR report key: 3874085 · Received June 16, 2014

    Report

    Report Number
    3003875359-2014-10166
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    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. ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE SCREWDRIVER SHAFTS HAS SHOWN THAT THE QUICK COUPLING IS DAMAGED AND THEREFORE THE PROPER FUNCTION IS NO LONGER ENSURED. THE ARTICLES WERE ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED, NO ABNORMAL FINDINGS WERE IDENTIFIED. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS INSTRUMENT WAS MANUFACTURED IN FEBRUARY 2008 ACCORDING TO THE SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES WERE FOUND. BASED ON THESE RESULTS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND IT APPEARS THAT HIGH APPLIED MECHANICAL FORCES CAUSED THIS DAMAGE. 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PROXIMAL ENDS OF THE SHAFTS ARE BROKEN, AND ONE OF THEIR PIECES REMAINED IN THE HANDLE SO THAT IS NO LONGER USABLE AS WELL. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352985 2.4MM STARDRIVE SCREWDRIVER SHAFT SCREWDRIVERS HXX SYNTHES HAGENDORF 1838534

    Patients

    Seq Age Sex Outcome Treatment
    1