BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED ACET INSERTR

    MDR report key: 3972618 · Received August 1, 2014

    Report

    Report Number
    1818910-2014-24533
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 19, 2014
    Report Date
    July 19, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. 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

    THE INVESTIGATION CONFIRMED THAT THE ANGLED ACET INSERTER HANDLE HAD FRACTURED AS REPORTED. PREVIOUS INVESTIGATIONS HAVE FOUND THAT DESIGN CHANGE WAS IMPLEMENTED FOR THIS PRODUCT (ECO-321614) TO PREVENT THE ANTI-ROTATION PIN FROM LOADING THE PLASTIC HANDLE TO MINIMISE FURTHER FAILURES OF THE HANDLE CRACKING. DRA-001725 WAS CREATED TO INVESTIGATE THE USE OF RADEL IN INSTRUMENTS AND CONCLUDED THAT THE DATA SHOWED NO SYSTEMATIC FAILURES OF EXTRUDED RADEL FOR USE IN INSTRUMENTS. FOLLOWING THE DRA A HHE WAS COMPLETED (DVA-108291-HHE) AND CONCLUDED THAT THE RISK IS MEDIUM AND THAT NO FURTHER ACTION IS NECESSARY. THE COMPLAINT SHALL BE CLOSED WITH A JUSTIFIED CONCLUSION IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. 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

    A LARGE PIECE OF THE HANDLE HAS BROKEN OFF AROUND THE HANDLE IMPACTING HEAD AREA. INSTRUMENT WAS FOUND IN A RETURNED LOAN KIT. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. THE INSTRUMENT HAD FURTHER BEEN ASSESSED BY DEPUY ENGINEERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451344 ANGLED ACET INSERTR HIP INSTRUMENT/TRIAL LXH DEPUY INTERNATIONAL LTD. 8010379 P28550001

    Patients

    Seq Age Sex Outcome Treatment
    1