BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZIMMER DTO 5.5 UTS ANTI-TORQUE

    MDR report key: 4820692 · Received June 3, 2015

    Report

    Report Number
    9613350-2015-00637
    Event Type
    Other
    Date Received
    June 3, 2015
    Date of Event
    April 24, 2015
    Report Date
    May 4, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PERFORMED FUNCTIONAL TEST CONFIRMS THE REPORTED ERROR PATTERN. IT WAS NOT POSSIBLE TO USE BOTH PARTS TOGETHER (DTO ANTI-TORQUE AND DTO SCREW DRIVER). THE MOVED PIN BLOCKED THE FUNCTION OF THE INNER DIAMETER OF THE TUBE. CHARACTERISTICS NO. 9 OF THE INSPECTION PLAN SAP MENTIONS THAT THE PIN HAS TO BE FLUSH TO THE HANDLE SURFACE. VISUAL INSPECTION WAS PERFORMED 100%. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO SAP DFMEA. INSTRUMENT MATING PART FUNCTIONALITY ISSUE DUE TO INAPPROPRIATE USE OR WRONG COMBINATIONS OF INSTRUMENTS OR IMPLANTS. INSTRUMENT MATING PART FUNCTIONALITY ISSUE DUE TO DAMAGE TO INSTRUMENT DUE TO MISHANDLING. INSTRUMENT MATING PART FUNCTIONALITY ISSUE DUE TO REPEATED CYCLES OF CLEANING / STERILIZATION PROCESS. INSTRUMENT MATING PART FUNCTIONALITY ISSUE DUE TO FATIGUE (REPEATED USES.) BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTD THAT THE SURGEON WAS USING A ZIMMER DTO 5.5 UTS ANTI-TORQUE, BUT HE WAS NOT ABLE TO FIX THE ZIMMER DTO 5.5 UTS SET SCREW DRIVER WITH IT BECAUSE THE TUBE WAS BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359990 ZIMMER DTO 5.5 UTS ANTI-TORQUE ZIMMER DTO UTS ANTI-TORQUE NQP ZIMMER GMBH NA 11.657324

    Patients

    Seq Age Sex Outcome Treatment
    1 Other