BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC* PATELLAR CEMENTING CLAMP

    MDR report key: 6013594 · Received October 10, 2016

    Report

    Report Number
    1818910-2016-28953
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 3, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    (B)(4). 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 RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF A MISSING SCREW. THE SOCKET HEAD SHOULDER SCREW (B)(4) IS MISSING FORM THE PATELLAR CLAMP. A COMPLAINT DATABASE SEARCH ON THE PROVIDED PRODUCT CODE DID NOT IDENTIFY A TREND OF MISSING/DISASSOCIATED SHOULDER SCREWS. WITH THE PROVIDED INFORMATION, A DEFINITIVE ROOT CAUSE IS UNKNOWN. BASED ON THE INABILITY TO DETERMINE A SPECIFIC ROOT CAUSE, A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. 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.

    Description of Event or Problem · 1

    THE GUIDE SCREW FELL OUT OF THE CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666019 PFC* PATELLAR CEMENTING CLAMP KNEE INSTRUMENTS HXD DEPUY ORTHOPAEDICS, INC. 1818910 GM0209

    Patients

    Seq Age Sex Outcome Treatment
    1