BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCEPT GRAFIX

    MDR report key: 20733158 · Received November 20, 2024

    Report

    Report Number
    1017294-2024-00135
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    October 25, 2024
    Report Date
    January 27, 2026
    Manufacturer
    CLASSIC WIRE CUT CO, INC.
    Product Code
    LXH
    UDI-DI
    10845854018255
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EXAMINATION OF THE RETURNED USED DEVICE, ITEM TS8850 FOUND TENDON STRIPPER TIP BROKEN OFF FROM THE SHAFT. THE BROKEN TIP WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, BASED UPON EVALUATION, PHOTO AND AN ADVERSE EVENT REVIEW MEETING, THE LIKELY CAUSE OF THIS EVENT WAS EXCESSIVE FORCE. A DEVICE HISTORY REVIEW (DHR) WAS REQUESTED FROM THE MANUFACTURER, AND NO INDICATION OF ABNORMALITIES WAS COMMUNICATED. 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 ONE COMPLAINT, REGARDING ONE DEVICE, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 372 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 0.003. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    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. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. DEVICE NOT YET RECEIVED.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, TS8850, CONCEPT GRAFIX TENDON STRIPPER, 7.0 MM, WAS BEING USED DURING AN ACL PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿THE TIP OF THIS TS8850 WAS BROKEN DURING GRAFT CUTTING.¿. FURTHER REPORTING STATES, ¿MORE INCISION TO TAKE OUT THE BROKEN TIP.¿ THE PROCEDURE WAS COMPLETED WITH ANOTHER TENDON STRIPPER. MORE INCISION WAS REQUIRED TO REMOVE THE TIP. THERE WAS NO REPORT OF EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF ¿MORE INCISION¿ REQUIRED TO RETRIEVE TIP.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, TS8850, CONCEPT GRAFIX TENDON STRIPPER, 7.0 MM, WAS BEING USED DURING AN ACL PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿THE TIP OF THIS TS8850 WAS BROKEN DURING GRAFT CUTTING.¿. FURTHER REPORTING STATES, ¿MORE INCISION TO TAKE OUT THE BROKEN TIP.¿ THE PROCEDURE WAS COMPLETED WITH ANOTHER TENDON STRIPPER. MORE INCISION WAS REQUIRED TO REMOVE THE TIP. THERE WAS NO REPORT OF EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF ¿MORE INCISION¿ REQUIRED TO RETRIEVE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2314278 CONCEPT GRAFIX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CLASSIC WIRE CUT CO, INC. 72331 10845854018255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R