BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL T-HANDLE

    MDR report key: 6115629 · Received November 19, 2016

    Report

    Report Number
    1818910-2016-31806
    Event Type
    Malfunction
    Date Received
    November 19, 2016
    Date of Event
    November 7, 2016
    Report Date
    December 8, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. (B)(4). 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

    THIS COMPLAINT REMAINS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE COMPLAINT OF HANDLE DAMAGE; THE HANDLE IS CRACKED. A COMPLAINT DATABASE SEARCH ON THE PROVIDED PRODUCT CODE IDENTIFIED SIMILAR REPORTS FOR HANDLE DAMAGE/BREAKAGE. A PREVIOUS EVALUATION FOUND 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. 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. 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

    HANDLE HAS CRACKED AT THE SHAFT INTERSECTION WITH THE HANDLE.

    Description of Event or Problem · 1

    INSTRUMENTS HAVE RETURNED FROM HOSPITAL AS IS. ITEM FOUND ON CHECK-IN. HANDLE HAS CRACKED AT THE SHAFT INTERSECTION WITH THE HANDLE. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. THE INSTRUMENT HAD FURTHER BEEN ASSESSED BY DEPUY ENGINEERING. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766349 EXCEL T-HANDLE HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. SO2019039

    Patients

    Seq Age Sex Outcome Treatment
    1