BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST APG SIZER PIN GUIDE 44+3

    MDR report key: 6057212 · Received October 26, 2016

    Report

    Report Number
    1818910-2016-30206
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Report Date
    October 24, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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). 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

    DEVICE AVAILABLE FOR EVALUATION. 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 DEVICE FOUND CHIPS AND WEAR AROUND THE GUIDE PIN HOLES. THE DAMAGE IS DUE TO REPETITIVE CONTACT WITH THE HEX DRIVER. THE ROOT CAUSE IS ATTRIBUTED TO DEVICE WEAR FROM NORMAL USE AND SERVICING. BASED ON THE ROOT CAUSE DETERMINATION OF DEVICE WEAR FROM NORMAL USE AND SERVICING, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. MONITOR COMPLAINTS THROUGH SEP-419. 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

    THE SIZER PIN GUIDES HAVE CHIPS IN THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708438 ST APG SIZER PIN GUIDE 44+3 SHOULDER INSTRUMENT/TRIAL HWT DEPUY ORTHOPAEDICS, INC. PG0511

    Patients

    Seq Age Sex Outcome Treatment
    1