BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET TAPER HEX SCDR RIGID

    MDR report key: 13540919 · Received February 16, 2022

    Report

    Report Number
    1818910-2022-02907
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    January 1, 2022
    Report Date
    February 16, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HXX
    UDI-DI
    10603295109235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED. EXAMINATION OF THE RETURNED DEVICE FOUND EVIDENCE OF WEAR. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. 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 · 0

    DEVICES 1 AND 2: REPORTED TO BE PART OF COMPLAINT - (B)(4). SALES REP - (B)(6). COMPLAINT AGE - 91 DAYS (USA) ISSUES - 1 LOT CODE MISMATCH, 1 EXTRA PRODUCT. PRODUCT CODES - 227447000 (X2). LOT CODES - SO2029518 AND AG0310. RECEIVED AT CG LABS - ON (B)(6) 2021 WITH TRACKING NUMBER 285687097462. SHIPPED FROM CGL TO (B)(4) - ON (B)(6) 2021 WITH TRACKING NUMBER 543572863782. SHIPPED FROM (B)(4) - (B)(6) 2021 WITH TRACKING NUMBER 775250501166. DECONTAMINATION RUN - NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528793 QUICKSET TAPER HEX SCDR RIGID HIP INSTRUMENTS : SCREWDRIVERS HXX DEPUY ORTHOPAEDICS INC US 2274-47-000 SO2029518 10603295109235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown