BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*CALIBRATED PAT CUT GDE

    MDR report key: 5634782 · Received May 5, 2016

    Report

    Report Number
    1818910-2016-18410
    Event Type
    Malfunction
    Date Received
    May 5, 2016
    Date of Event
    April 20, 2016
    Report Date
    April 26, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE 865034 PFC*CALIBRATED PAT CUT GDE ASSOCIATED WITH THE REPORTED EVENT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND ADDITIONAL REPORTS OF SAW CAPTURE BREAKAGE AGAINST PRODUCT CODE 865034. THE PREVIOUS REPORTS WERE INVESTIGATED AND THE ROOT CAUSES ATTRIBUTED TO PRODUCT WEAR OUT THROUGH NORMAL USE AND SERVICING. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE CURRENT REPORTED EVENT WITHOUT THE INSTRUMENT TO EXAMINE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. CONTINUE TO MONITOR VIA (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE SAW CAPTURE MECHANISM ON ONE SIDE OF THE CLAMP BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288221 PFC*CALIBRATED PAT CUT GDE KNEE INSTRUMENT/TRIAL HWT DEPUY ORTHOPAEDICS, INC. NB57899

    Patients

    Seq Age Sex Outcome Treatment
    1