BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION MIS TOTAL KNEE PROCEDURE TIBIAL BROACH IMPACTOR

    MDR report key: 1070978 · Received July 3, 2008

    Report

    Report Number
    1822565-2008-00394
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 5, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWA
    Removal / Correction Number
    1822565-07/01/2008-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED BROACH IMPACTOR HAS ONE OF THE JAWS FRACTURED OFF FROM THE BASE. THE KNURLED SECTION OF THE INSTRUMENT SHOWS IMPACTION MARKS ON THE ANTERIOR SIDE INDICATING THAT THE DEVICE WAS IMPACTED OFF-AXIS CAUSING ADDITIONAL BENDING MOMENT AND THE JAW FRACTURED DUE TO OVERLOAD. IMPROPER USE OF THE DEVICE APPEARS TO BE THE CAUSE OF THE PROBLEM. A FIELD COMMUNICATION WAS RELEASED JANUARY 2008 FOR PROPER EXTRACTION TECHNIQUE OF THE BROACH IMPACTOR. IN ADDITION, A NEW DESIGN HAS BEEN IMPLEMENTED THAT CAN SUCCESSFULLY WITHSTAND OFF-AXIS LOADING. A PRODUCT REMOVAL OF ALL PREVIOUS DESIGN ITERATIONS WAS INITIATED ON 06/30/08. EVALUATION: THE FRACTURED TAB WAS NOT RETURNED WITH THE COMPLAINT FOR REVIEW. THE DEVICE MEETS SPECIFICATIONS AS MEASURED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT BROACH IMPACTOR IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION MIS TOTAL KNEE PROCEDURE TIBIAL BROACH IMPACTOR KNEE INSTRUMENT HWA ZIMMER, INC. NA 60356560

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK