BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD WISHBONE ASSEMBLY

    MDR report key: 16773296 · Received April 19, 2023

    Report

    Report Number
    3004608878-2023-00071
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Report Date
    June 8, 2023
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FFO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    FAILURE ANALYSIS: AFTER EVALUATION, THE HANDLE ASSEMBLY WAS REPLACED ALONG WITH SOME NEEDED SMALL PARTS (CAM BEARINGS, CAM BOLT, CAM BUSHING). THE NUT, WASHER AND RING WERE REPLACED FOR ROUTINE OVERHAUL. BOTH WISHBONE ARM ASSEMBLIES WERE REPLACED. THE UNIT HAS BEEN SUBJECTED TO A SUCCESSFUL FUNCTION CHECK. ROOT CAUSE ANALYSIS: BASED ON THE EVALUATION BY INTEGRA SERVICE AND REPAIR, THE ROOT CAUSE IS MOST LIKELY MISHANDLING OF THE PRODUCT LEADING TO DAMAGES. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY WAS IDENTIFIED FOR CORRECTION AS A RESULT OF THIS COMPLAINT INVESTIGATION.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT DURING ABDOMINAL SURGERY, THERE WAS BREAKAGE OF THE STANDARD WISHBONE ASSEMBLY (4020). IT WAS REPORTED THAT THE MEDICAL STAFF WAS ABLE TO FINISH THE PROCEDURE. THERE WAS APPROXIMATELY A 30-MINUTE INCREASE IN SURGERY TIME; HOWEVER, NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442192 STANDARD WISHBONE ASSEMBLY SURGICAL RETRACTOR FFO INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown