BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED ACET INSERTR

    MDR report key: 5395984 · Received January 28, 2016

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    Report

    Report Number
    1818910-2016-12141
    Event Type
    Malfunction
    Date Received
    January 28, 2016
    Date of Event
    January 15, 2016
    Report Date
    January 18, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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

    CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT STATES ORTHOKIT RECEIVED A REPORT OF ITEM 920010029 LOT PC34371001 BROKE IN SURGERY. PLASTIC LOCKING SLEEVE USED TO FIX CUP ONTO IMPACTOR DID NOT WORK THE INVESTIGATION COULD NOT CONFIRM THE FAILURE MODE AS THE FULL DEVICE WAS NOT RETURNED. PREVIOUSLY A CORRECTIVE ACTION WAS IDENTIFIED FOR THIS FAILURE MODE WHEREBY A DESIGN CHANGE WAS IMPLEMENTED AND ROUTED ON ECO-193427 (DWG-106984) IN 2007 IN ORDER TO STRENGTHEN THE LOCKING CATCH. THE DESIGN VERIFICATION WAS COMPLETED AND ROUTED ON DVA-101743-FDE AND CONCLUDED THAT THERE ARE NO OUTSTANDING ACTIONS IDENTIFIED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. DEPUY STILL 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.

    Description of Event or Problem · 1

    INSTRUMENT BROKE IN SURGERY, PLASTIC LOCKING SLEEVE USED TO FIX CUP ONTO IMPACTOR DID NOT WORK. THIS PART HAS BEEN THROWN AWAY BY THE HOSPITAL. NO DELAY OR HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55930 ANGLED ACET INSERTR HIP INSTRUMENT/TRIAL HWR DEPUY ORTHOPAEDICS, INC. PC34371001

    Patients

    Seq Age Sex Outcome Treatment
    1