BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREW FOR PFNA BLADE

    MDR report key: 3980199 · Received August 5, 2014

    Report

    Report Number
    9612488-2014-10317
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 8, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWB
    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. 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(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 EVALUATION WAS COMPLETED: THE INVESTIGATION OF THE COMPLAINED EXTRACTION SCREW SHOWS THAT THE TIP BROKE OFF. THE AVAILABLE DIMENSIONS WERE CHECKED AND FOUND TO BE IN ACCORDANCE WITH OUR SPECIFICATIONS. FURTHER INVESTIGATION REGARDING THE MANUFACTURING AND RAW MATERIAL DOCUMENTS FOR THE EXTRACTION SCREW PRODUCED IN 2006 SHOWS CONFORMITY TO SPECIFICATION AS WELL. IT IS LIKELY THAT A MECHANICAL OVERLOADING SITUATION HAVE LED TO THE BREAKAGE. THE AREA BELOW THE THREAD OF THE TIP SHOWS SCRATCHES WHICH SUGGEST FURTHER MECHANICAL IMPACTS WHICH COULD FINAL INTO THE TIP BREAK TOO. NO PRODUCT FAULT COULD BE DETECTED. 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)(4) REPORTS AN EVENT IN (B)(6) HAS FOLLOWS: IT WAS REPORTED THAT THE DISTAL END OF THE EXTRACTION SCREW BROKE DOWN, JUST WHEN CONNECTING IT TO THE BLADE. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458032 EXTRACTION SCREW FOR PFNA BLADE EXTRACTOR HWB SYNTHES BETTLACH 2168449

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR