BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*CALIBRATED PAT CUT GDE

    MDR report key: 4143458 · Received October 6, 2014

    Report

    Report Number
    1818910-2014-29437
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED CUTTING GUIDE CONFIRMED ONE OF THE TWO SAW CAPTURES HAS BROKEN. THE ROOT CAUSE IS BEING ATTRIBUTED TO PRODUCT WEAR OUT BASED ON THE OVERALL CONDITION OF THE RETURNED DEVICE. BASED ON THE INVESTIGATION DETERMINATION OF WEAR OUT AS THE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. ALTHOUGH THIS INVESTIGATION DID NOT ESTABLISH THE NEED FOR CORRECTIVE ACTION, A NEW PATELLA RESECTION GUIDE 950501121 SIGMA HP PAT RES GUIDE HAS BEEN DESIGNED. 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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. FOLLOW UP COMMUNICATION FOR PRODUCT RETURN WAS UNSUCCESSFUL. A COMPLAINT DATABASE SEARCH FINDS ADDITIONAL REPORTS OF BREAKAGE AGAINST THE PROVIDED PRODUCT CODE. THE PREVIOUS INVESTIGATIONS FOUND EVIDENCE OF PRODUCT WEAR OUT AS THE ROOT CAUSE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. 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. CONTINUE TO MONITOR VIA SEP-419. 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.

    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.

    Description of Event or Problem · 1

    PATELLA CUTTING GUIDE BROKE DURING NORMAL USE. ALL PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623233 PFC*CALIBRATED PAT CUT GDE KNEE INSTRUMENTS LXH DEPUY ORTHOPAEDICS, INC. 1818910 JO606

    Patients

    Seq Age Sex Outcome Treatment
    1