BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER SHAFT 1.5

    MDR report key: 3201171 · Received July 2, 2013

    Report

    Report Number
    1719045-2013-01746
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 9, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS THERE ARE NO NCR DOCUMENTS IN THE DHR FILE. SUBJECT MANUFACTURING LOT 7010083 PASSED ALL INSPECTIONS AND CERTIFICATION TESTING DURING MANUFACTURING. OUR INVESTIGATION HAS SHOWN THAT THE RETURNED SCREWDRIVER TIP IS INDEED BADLY TWISTED. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LEAD TO THIS OCCURRENCE. IT IS POSSIBLE THAT TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED DURING THE SCREW INSERTION. WE ARE AWARE OF THE FACT THAT THESE ARE DELICATE INSTRUMENTS WHICH REQUIRE DILIGENT HANDLING. THE MEASURABLE DIMENSIONS OF THE DEFORMED SCREWDRIVER WERE CHECKED AS FAR AS POSSIBLE AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED. (B)(4)

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING OPERATION WITH THE SCREWDRIVER SHAFT WITH HOLDING SLEEVE 03.114.009, INCLUDING 03.114.010 LOT 7010083 THE SCREWDRIVER PART 03.114.010 BECAME DEFORMED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303392 SCRDRIVER SHAFT 1.5 HXX SYNTHES MONUMENT 7010083

    Patients

    Seq Age Sex Outcome Treatment
    1