BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED ACET INSERTR

    MDR report key: 4110318 · Received September 23, 2014

    Report

    Report Number
    1818910-2014-28618
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE INVESTIGATION CONFIRMED THAT THE ANGLED ACET INSERTER HANDLE HAD FRACTURED AS REPORTED ON BOTH THE RETURNED DEVICES. PREVIOUS INVESTIGATIONS HAVE FOUND THAT DESIGN CHANGE WAS IMPLEMENTED FOR THIS PRODUCT ((B)(4)) TO PREVENT THE ANTI-ROTATION PIN FROM LOADING THE PLASTIC HANDLE TO MINIMISE FURTHER FAILURES OF THE HANDLE CRACKING. (B)(4) WAS CREATED TO INVESTIGATE THE USE OF (B)(4) IN INSTRUMENTS AND CONCLUDED THAT THE DATA SHOWED NO SYSTEMATIC FAILURES OF EXTRUDED (B)(4) FOR USE IN INSTRUMENTS. FOLLOWING THE DRA A HHE WAS COMPLETED ((B)(4)) AND CONCLUDED THAT THE RISK IS MEDIUM AND THAT NO FURTHER ACTION IS NECESSARY. THIS PRODUCT IS FROM A BATCH PREVIOUS TO THE DESIGN CHANGE ROUTED ON (B)(4) AS THE ANTI-ROTATION PIN CAN BE VISUALLY SEEN ON BOTH THE DEVICES. THE COMPLAINT SHALL BE CLOSED WITH A JUSTIFIED CONCLUSION IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS.

    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.

    Description of Event or Problem · 1

    THE HANDLE IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592572 ANGLED ACET INSERTR HIP INSTRUMENT/TRIAL LXH 1818910 DEPUY ORTHOPAEDICS, INC. P25002001

    Patients

    Seq Age Sex Outcome Treatment
    1