BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*CALIBRATED PAT CUT GDE

    MDR report key: 5884047 · Received August 17, 2016

    Report

    Report Number
    1818910-2016-25315
    Event Type
    Malfunction
    Date Received
    August 17, 2016
    Date of Event
    August 15, 2016
    Report Date
    August 15, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). DEPUY SYNTHES HAS BEEN INFORMED THAT THE LOT NUMBER IS NOT AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED, D FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THE REPORTED EVENT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO ADDITIONAL REPORTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. 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 DEVICE TO EXAMINE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. 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.

    Description of Event or Problem · 1

    PATELLA CLAMP BROKE DURING CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535777 PFC*CALIBRATED PAT CUT GDE KNEE INSTRUMENTS LXH DEPUY ORTHOPAEDICS, INC. 1818910 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR