BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITYTM ANTEROMEDIAL GUIDE R 9/10MM

    MDR report key: 11580918 · Received March 29, 2021

    Report

    Report Number
    1017294-2021-00144
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    February 22, 2021
    Report Date
    May 4, 2021
    Manufacturer
    CONMED CORPORATION
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT IS CONFIRMED. CUSTOMER EVENT "TIP BROKE OFF" WAS CONFIRMED BASED ON DEVICE EVALUATION. THE EVALUATION OF RETURNED USED DEVICE, ITEM KBR191 FOUND TIP DETACHED FROM THE SHAFT. CRITICAL DIMENSIONS WERE INSPECTED AND COULD NOT FIND ANY DISCREPANCIES. DETACHED TIP WAS NOT RETURNED PER EVALUATION. A DHR REVIEW FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS REPORTED EVENT. A TWO-YEAR LOT HISTORY REVIEW WAS CONDUCTED AND FOUND A TOTAL OF 3 SIMILAR EVENTS INVOLVING 3 DEVICES FOR THIS LOT NUMBER. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 8 COMPLAINTS, REGARDING (B)(4) 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 THE FOLLOWING: PRIOR TO USE, REMOVE ALL PROTECTIVE PACKAGING AND TIP PROTECTOR, IF APPLICABLE. INSPECT INSTRUMENTS PRIOR TO USE TO ENSURE THEY ARE IN GOOD PHYSICAL CONDITION AND FUNCTION PROPERLY. THERE SHOULD BE NO LOOSE, BROKEN, OR MISALIGNED PARTS. INSPECT INSTRUMENTS FOLLOWING USE TO ENSURE DEVICE INTEGRITY IS INTACT. THERE SHOULD BE NO LOOSE, BROKEN, OR MISSING PARTS. DO NOT USE EXCESSIVE FORCE ON INSTRUMENTS TO AVOID DAMAGE OR BREAKAGE DURING USE. DO NOT USE INSTRUMENTS TO PRY, AS BENDING OR BREAKAGE MAY OCCUR. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE KBR-191 DEVICE WAS BEING USED DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2021 WHEN IT WAS REPORTED THAT "THE TIP BROKE OFF." THEY WERE ABLE TO RETRIEVE THE BROKEN PIECE. THERE WAS NO REPORT OF IMPACT OR INJURY TO THE MALE PATIENT. THERE WAS NO DELAY TO THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480448 INFINITYTM ANTEROMEDIAL GUIDE R 9/10MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CONMED CORPORATION 1047129

    Patients

    Seq Age Sex Outcome Treatment
    1