BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET DEPTH GAUGE 70MM

    MDR report key: 10428151 · Received August 19, 2020

    Report

    Report Number
    1818910-2020-18447
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    August 11, 2020
    Report Date
    August 11, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HJT
    UDI-DI
    10603295109358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (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

    IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND BROKEN IN THE SETS. TIP OF THE BIMENTUM PLASTIC INSERT WAS BROKEN OFF AT THE BASE. BOTH DEPTH GAUGES ARE SHEARED OFF AT THE BASE. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889002 QUICKSET DEPTH GAUGE 70MM HIP INSTRUMENTS : DRILL GUIDES HJT DEPUY ORTHOPAEDICS INC US 2274-60-000 10603295109358

    Patients

    Seq Age Sex Outcome Treatment
    1