BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALIST*2 UNIVERSAL HANDLE

    MDR report key: 4943566 · Received July 27, 2015

    Report

    Report Number
    1818910-2015-26602
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THE REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE REPORTED PRODUCT LOT CODE J1005 INDICATES A MANUFACTURE DATE OF OCTOBER OF 2005. REVIEW OF A PROVIDED PHOTOGRAPH OF THE DEVICE CONFIRMED BREAKAGE OF THE SQUARE-TO-CIRCULAR (.183 DIMENSION) CROSS-SECTION FEATURE. A DESIGN MODIFICATION TO CHANGE TO THE UNDERCUT DETAILS OF THE SQUARE-TO-CIRCULAR (.183 DIMENSION) CROSS-SECTION WAS IMPLEMENTED IN DECEMBER 2012 VIA (B)(4) TO REDUCE INCIDENCE OF INSTRUMENT FAILURE. A SEARCH OF THE COMPLAINT DATABASE AGAINST PRODUCT CODE 966520 DID NOT FIND ANY REPORTS OF FRACTURE MANUFACTURED AFTER THE DECEMBER 2012 DESIGN MODIFICATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE CURRENT REPORTED EVENT WITHOUT THE INSTRUMENT TO EXAMINE. THE CURRENT REPORTED 966520 SP2 UNIVERSAL HANDLE WAS MANUFACTURED PRIOR TO THE DESIGN MODIFICATION IN DECEMBER OF 2012. THE NEED FOR FURTHER CORRECTIVE ACTION IS NOT INDICATED. MONITOR FOR REPORTED EVENTS OF FRACTURE FOR SP2 UNIVERSAL HANDLES MANUFACTURED AFTER DECEMBER 2012. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    DURING USE TO INSERT THE TIBIAL COMPONENT A PIECE OF THE HANDLE FRACTURED OFF. NO HARM WAS DONE TO PATIENT. NO PIECES WERE LEFT IN THE PATIENT. THERE WAS NO DELAY TO SURGERY AS HANDLE STILL USEABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487204 SPECIALIST*2 UNIVERSAL HANDLE KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. J1005

    Patients

    Seq Age Sex Outcome Treatment
    1