BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROACH CORAIL AMT 10

    MDR report key: 6067351 · Received October 31, 2016

    Report

    Report Number
    1818910-2016-30511
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 26, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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

    THE COMPLAINT STATES INTRAOPERATIVELY THE CONNECTION MECHANISM OF RASP BROKE OFF. A COMPLAINT DATABASE SEARCH DID NOT IDENTIFY ANY ANOMALIES. CONCLUSION: THE BROACH CARRIES SIGNS OF WEAR AND TEAR THROUGH NORMAL USE. WITH PROVIDED INFORMATION AND PRODUCT RETURNED FOR INSPECTION IT CAN BE DETERMINED THAT THE ROOT CAUSE OF COMPLAINT IS WEAR AND TEAR (AS (B)(4)). THE COMPLAINT SHALL BE CLOSED WITH A JUSTIFIED CONCLUSION; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. POST MARKET SURVEILLANCE IS PER (B)(4). 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.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). FOLLOWUP WITH THE COMPLAINANT HAS BEEN CONDUCTED FOR THE LOT NUMBER, AND THE INFORMATION IS NOT AVAILABLE. 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

    INTRAOPERATIVELY THE CONNECTION MECHANISM OF RASP BROKE OFF. SURGERY TIME PROLONGATION ABOUT 40 MINUTES. NO PATIENT HARM AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719636 BROACH CORAIL AMT 10 HIP INSTRUMENT/TRIAL HTQ DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR