BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KPS ADJUSTABLE FREE LOOP

    MDR report key: 18093083 · Received November 8, 2023

    Report

    Report Number
    1017294-2023-00103
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 17, 2023
    Report Date
    December 15, 2023
    Manufacturer
    CONMED LARGO
    Product Code
    MBI
    UDI-DI
    30845854649088
    PMA / PMN Number
    K191204
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, A DEVICE MALFUNCTION CANNOT BE VERIFIED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 45 COMPLAINTS, REGARDING 46 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT FAILURE TO SIZE THE DIAMETER OF THE TUNNEL RELATIVE TO THE GRAFT PROPERLY MAY RESULT IN SUTURE BREAKAGE DUE TO EXCESSIVE FORCE REQUIRED TO ADVANCE THE GRAFT. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE KFL100, KPS ADJUSTABLE FREE LOOP WAS BEING USED DURING AN ACL & PCL WITH MENISCUS REPAIR PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿BROKE DURING THE SURGERY TIMING.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS REMOVED FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE KFL100, KPS ADJUSTABLE FREE LOOP WAS BEING USED DURING AN ACL & PCL WITH MENISCUS REPAIR PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿BROKE DURING THE SURGERY TIMING.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS REMOVED FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743928 KPS ADJUSTABLE FREE LOOP FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CONMED LARGO 1311376 30845854649088

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown