BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHRO TISSLIB ATRAUMATIC UP *EA

    MDR report key: 20891851 · Received December 10, 2024

    Report

    Report Number
    1221934-2024-04386
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 25, 2024
    Report Date
    December 10, 2024
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    NBH
    UDI-DI
    10886705004041
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: THE COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER, THEREFORE NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS AND UNAVAILABLE FOR A PHYSICAL EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCE WAS IDENTIFIED. BASED ON THE CURRENT AVAILABLE INFORMATION, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AND THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE ARTHRO TISSLIB ATRAUMATIC UP DEVICE IDEAL SUTURE SHUTTLE BENT DURING CASE. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476641 ARTHRO TISSLIB ATRAUMATIC UP *EA ACCESSORIES, ARTHROSCOPIC NBH DEPUY MITEK LLC US 24C03 10886705004041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown