BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RGDLOOP ADJUSTABLE STND

    MDR report key: 19233818 · Received May 2, 2024

    Report

    Report Number
    1221934-2024-01452
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 2, 2024
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MBI
    UDI-DI
    10886705024094
    PMA / PMN Number
    K140324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: D10, CONCOMITANT MEDICAL DEVICES AND THERAPY DATES, VAPR S90 4.0MM W/INTEGR HDP DEVICE, (B)(6) 2023. UDI: (B)(4). D4, EXPIRATION DATE AND H4 MANUFACTURE DATE ARE UNKNOWN. THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. SINCE THE COMPLAINT DEVICE WAS DISCARDED, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF ADDITIONAL INFORMATION OR THE DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER AND NO NON-CONFORMANCE WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE THE RGDLOOP ADJUSTABLE STND DEVICE WAS BEING USED WHEN THE SUTURE BROKE. THE VAPR S90 4.0MM W/INTEGR HDP -EAA DEVICE WAS BEING USED WHEN THE DEVICE GENERATED SPARKS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438683 RGDLOOP ADJUSTABLE STND FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI MEDOS INTERNATIONAL SàRL 9L67180 10886705024094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown