BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION STEMMED TIBIAL BROACH IMPACTOR

    MDR report key: 1032402 · Received April 17, 2008

    Report

    Report Number
    1822565-2008-00186
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 18, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS RETURNED, THE LOCKING PIN AND SPRING HAVE DISASSEMBLED FROM THE BROACH IMPACTOR. THE THUMB PIN DISASSEMBLED FROM THE DEVICE AND WAS NOT RETURNED FOR REVIEW. A PRODUCT IMPROVEMENT WAS IMPLEMENTED UTILIZING EB WELD BETWEEN THE THUMB PIN AND THE LOCKING PIN TO ADDRESS THIS ISSUE. THE REPORTED MALFUNCTION HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY IN THE PREVIOUS TWO YEARS ON A SAME OR SIMILAR DEVICE. AS A RESULT, THIS REPORT IS BEING SUBMITTED IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING FOR MANUFACTURES GUIDANCE DOCUMENT PUBLISHED BY THE FDA IN MARCH OF 1997.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON WAS PERFORMING A ROUTINE TOTAL KNEE ARTHROPLASTY WHEN THE SCRUB NURSE NOTICED THE PIN FROM THE IMPACTOR WAS MISSING AFTER BEING USED. X-RAYS WERE TAKEN OF THE PT'S KNEE, BUT THE PIN HAS NOT BEEN SEEN. THE PIN HAS NOT BEEN FOUND. THE SURGERY WAS DELAYED THIRTY MINUTES BECAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION STEMMED TIBIAL BROACH IMPACTOR KNEE INSTRUMENT HWA ZIMMER, INC. NA 50435900

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK