BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL T-HANDLE

    MDR report key: 11890016 · Received May 26, 2021

    Report

    Report Number
    1818910-2021-11301
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Report Date
    May 17, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295079941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: T-HANDLES BROKE DUE TO WEAR AND TEAR. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. HOWEVER, A REVIEW OF THE PROVIDED PHOTOGRAPH FOUND THE HANDLE IS CRACKED. A COMPLAINT DATABASE SEARCH ON THE PROVIDED PRODUCT CODE IDENTIFIED SIMILAR REPORTS FOR HANDLE DAMAGE/BREAKAGE. PREVIOUS INVESTIGATIONS FOUND BASED ON THE DATA ACQUIRED DURING FAILURE ANALYSIS OF (B)(4), THE T-HANDLES ARE CRACKING DUE TO ENVIRONMENTAL STRESS CRACKING. THIS IS DUE TO THE COMBINATION OF NORMAL LOADING OR USAGE OF THE INSTRUMENT AND EXPOSURE TO CHEMICALS THEY ARE NOT INTENDED TO BE (NON-COMPLIANT TO CLEANING GUIDELINES) LEADING TO WEAKENING OF THE MATERIAL OVER TIME. A PREVIOUS INVESTIGATION (B)(4) WAS CONDUCTED BY COMMERCIALIZED PRODUCT DEVELOPMENT TO DETERMINE IF A PRODUCT IMPROVEMENT IS NECESSARY. DRA-004006 WAS COMPLETED IN (B)(6) 2016 AND CONCLUDED NO DESIGN SOLUTIONS IDENTIFIED WHICH WOULD REDUCE THE RISK OF HANDLE FRACTURE WITHOUT INTRODUCING NEW RISK. BASED ON THE DETERMINATION OF ENVIRONMENTAL STRESS CRACKING AS THE ROOT CAUSE, NO FURTHER CORRECTIVE ACTION IS BEING PURSUED AT THIS TIME. CONTINUE TO MONITOR COMPLAINTS UNDER POST MARKET SURVEILLANCE SEP-419. DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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

    2X T-HANDLES ON THEIR C-STEM TRAYS HAS BROKEN DUE TO WEAR AND TEAR. THESE SETS HAVE BEEN TAKEN OUT OF CIRCULATION SO THERE IS NO IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780029 EXCEL T-HANDLE HIP INSTRUMENTS : HANDLES LXH DEPUY ORTHOPAEDICS INC US 2001-42-000 10603295079941

    Patients

    Seq Age Sex Outcome Treatment
    1