BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APG+ SIZER PIN GUIDE 44+0

    MDR report key: 6043592 · Received October 20, 2016

    Report

    Report Number
    1818910-2016-29846
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 17, 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: THE 223600002 APG+ SIZER PIN GUIDE 44+0, LOT CODE PG250507, ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE 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. 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

    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.

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO INSERT THE 44/0 GLENOID SIZER GUIDE ON TO THE HANDLE PROVIDED, THE PLASTIC SNAPPED ON THE TOP OF THE GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695218 APG+ SIZER PIN GUIDE 44+0 SHOULDER INSTRUMENT/TRIAL HWT DEPUY ORTHOPAEDICS, INC. PG250507

    Patients

    Seq Age Sex Outcome Treatment
    1