BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVERS

    MDR report key: 4141495 · Received October 4, 2014

    Report

    Report Number
    2520274-2014-13889
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Report Date
    September 9, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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. A MANUFACTURING EVALUATION WAS COMPLETED: THE BROKEN SCREWDRIVER WAS CHECKED AS FAR AS POSSIBLE AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE VIEW OF THE BROKEN SURFACES DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE, WHICH INDICATES MATERIAL CONFORMITY AS WELL. THE INVESTIGATION OF THE COMPLAINED SCREWDRIVER HAS SHOWN THAT THE COUPLING IS BROKEN. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS OCCURRENCE. IT IS LIKELY THAT TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED DURING THE SURGERY. FURTHER INVESTIGATION HAS SHOWN THAT THIS INSTRUMENT WAS MANUFACTURED IN JANUARY 2010 ACCORDING TO THE SPECIFICATION. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE UNKNOWN SCREWDRIVER/UNKNOWN PART NUMBER. 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:HE SOCKET OF THE SCREWDRIVER IS BROKEN. UNKNOWN WHEN EVENT HAPPENED, BUT NO INDICATION THAT THERE WAS A PATIENT INVOLVED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621278 SCREWDRIVERS HXX SYNTHES OBERDORF 1001

    Patients

    Seq Age Sex Outcome Treatment
    1