BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY RETRO-REAMER, 10MM

    MDR report key: 14955694 · Received July 8, 2022

    Report

    Report Number
    1017294-2022-00077
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    June 21, 2022
    Report Date
    August 4, 2022
    Manufacturer
    CONMED LARGO
    Product Code
    GFG
    UDI-DI
    20845854902025
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    CORRECTION: D4.LOT NUMBER WAS CORRECTED FROM 1232757 TO LOT NUMBER:1230761 AS NEW INFORMATION WAS PROVIDED SINCE INITIAL FILING. MANUFACTURER NARRATIVE: CUSTOMER EVENT ¿REAMER TIP SHATTERED INSIDE PATIENT¿ WAS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE AND DEVICE EVALUATION. VISUAL EXAMINATION OF THE RETURNED DEVICE ITEM KRR100, FOUND DEVICE BROKEN OFF AT THE TIP, BROKEN PIECE WAS NOT RETURNED FOR EVALUATION. ALSO, EVALUATION FOUND REAMER CAP BROKEN OFF. 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. A TWO-YEAR LOT HISTORY REVIEW WAS CONDUCTED AND FOUND A TOTAL OF 2 SIMILAR EVENTS INVOLVING 2 DEVICES FOR THIS LOT NUMBER. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 5 COMPLAINTS, REGARDING 5 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED 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. EXERCISE CARE IN THE USE OF THE HANDPIECE HOLDING THE REAMER TO MINIMIZE SIDE OR BENDING LOADS TO THE REAMER WHICH MAY CAUSE REAMER BREAKAGE AND/OR OVERSIZED TUNNELS. EXCESSIVE FORCE APPLIED DURING RETROGRADE DRILLING CAN LEAD TO REDUCED SOCKET SIZES. THIS ISSUE WILL CONTINUE TO BE MONITORED 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 KRR100, INFINITY RETRO-REAMER, 10MM WAS BEING USED DURING AN ACL RECONSTRUCTION ON (B)(6) 2022 WHEN IT WAS REPORTED THAT THE ¿REAMER TIP SHATTERED INSIDE PATIENT WHEN RETRO REAMING THE FEMORAL SOCKET. THE DOCTOR HAD TO FISH OUT 2 PIECES OF THE TIP FROM INSIDE THE JOINT.¿ THE PROCEDURE WAS COMPLETED WITH REPORT OF A 10-MINUTE DELAY TO THE CASE. FURTHER ASSESSMENT FOUND THE REAMER TIP WAS REMOVED FROM INSIDE THE JOINT USING A GRASPER. THERE WAS NO INJURY TO THE PATIENT AND NO MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION WAS REQUIRED FOR THE PATIENT. THE PATIENT IS SAID TO BE OKAY AND UNHARMED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE KRR100, INFINITY RETRO-REAMER, 10MM WAS BEING USED DURING AN ACL RECONSTRUCTION ON (B)(6) 22 WHEN IT WAS REPORTED THAT THE ¿REAMER TIP SHATTERED INSIDE PATIENT WHEN RETRO REAMING THE FEMORAL SOCKET. THE DOCTOR HAD TO FISH OUT 2 PIECES OF THE TIP FROM INSIDE THE JOINT.¿ THE PROCEDURE WAS COMPLETED WITH REPORT OF A 10-MINUTE DELAY TO THE CASE. FURTHER ASSESSMENT FOUND THE REAMER TIP WAS REMOVED FROM INSIDE THE JOINT USING A GRASPER. THERE WAS NO INJURY TO THE PATIENT AND NO MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION WAS REQUIRED FOR THE PATIENT. THE PATIENT IS SAID TO BE OKAY AND UNHARMED. 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
    1986297 INFINITY RETRO-REAMER, 10MM BIT, SURGICAL GFG CONMED LARGO KRR100 1230761 20845854902025

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown