BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSET TPRD HEX SCDR U-JOINT

    MDR report key: 6103369 · Received November 15, 2016

    Report

    Report Number
    1818910-2016-31434
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 14, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 INSTRUMENT CONFIRMED THE MAJORITY OF THE TIP BROKE OFF. ORIGINALLY, DATA WAS REVIEWED UNDER THE ROOT CAUSE INVESTIGATION DRA-004082. IT WAS DETERMINED AS A RESULT OF THE INVESTIGATION TO CONDUCT A PRELIMINARY RISK ASSESSMENT. PRA 103139360 WAS CONDUCTED IN APRIL 2015 AND DETERMINED THAT THERE HAD BEEN NO INCREASE IN PATIENT HARM AND THAT THE SEVERITY AND OCCURRENCE OF THE VARIOUS FAILURE MODES RESULTED IN BROADLY ACCEPTABLE RISKS. HOWEVER, BECAUSE OF THE POTENTIAL FOR VARIOUS HARMS OF HIGHER SEVERITY, AND TO ATTEMPT TO IMPROVE CUSTOMER SATISFACTION, THE FRACTURE FAILURES WILL BE FURTHER INVESTIGATED WITHIN A PREVENTATIVE CAPA (CAPA-(B)(4)) THAT WAS CREATED ON JUNE 11, 2015. 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 SCREWDRIVER BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753556 QUICKSET TPRD HEX SCDR U-JOINT HIP INSTRUMENT/TRIAL HXX DEPUY ORTHOPAEDICS, INC. 1818910 A1209

    Patients

    Seq Age Sex Outcome Treatment
    1