BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION CONICAL REAMER

    MDR report key: 1012702 · Received March 12, 2008

    Report

    Report Number
    1822565-2008-00095
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Report Date
    February 12, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO PRODUCT OR LOT NUMBERS WERE PROVIDED. THE DESIGN INTENT OF THIS CONNECTION BETWEEN THE DRIVER AND THE BASE PLATE DRILLS, REAMERS, AND PLUG WAS TO PROVIDE A CONNECTION WHICH DID NOT REQUIRE A LOCK SCREW, OR OTHER THREADED FEATURE. IF THE DRIVER IS ROTATED COUNTER-CLOCKWISE WHILE THE ATTACHED DEVICE IS NOT, IT WILL RELEASE THE CONNECTION. THE TABS ON THE DRIVER SHOULD RESTRAIN THE ATTACHED DEVICE AS LONG AS THEY HAVE BEEN ROTATED CLOCKWISE FROM THE ASSEMBLY ORIENTATION. THE SURGICAL TECHNIQUE DESCRIBES THE ATTACHMENT METHOD. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON FEELS THAT EVEN WHEN YOU REAM SLOWLY, THE REAMER GRABS AT THE BONE BECAUSE THERE IS TOO MUCH SPACE BETWEEN EACH CUTTING EDGE. THE SURGEON CLAIMS THAT IT DOESN'T SEEM TO REAM VERY SMOOTHLY AND THAT MORE CUTTING TEETH SHOULD BE ADDED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION CONICAL REAMER SHOULDER INSTRUMENT HTO ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1