BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNESYS HEX-TIP FOR TORQUE DRIVER 425

    MDR report key: 1919270 · Received December 1, 2010

    Report

    Report Number
    9613350-2010-00552
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    NQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. THE MFR DID NOT YET RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. IT IS NOT SUSPECTED THAT THE ALLEGED EVENT WAS CAUSED BY DEVICE FAILURE. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING THE FINAL LOCKING OF THE LITTLE SCREW IN THE SACRUM, LEFT, THE HANDLE AND THE HEXAGONAL TIP OF THE SCREWDRIVER BROKE. THE HEXAGONAL TIP BRAKE WAS TRAPPED IN THE SCREW AND COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNESYS HEX-TIP FOR TORQUE DRIVER 425 DYNESYS INSTRUMENTS NQP ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other