BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCEPT GRAFIX TENDON STRIPPER 7.0MM

    MDR report key: 8607506 · Received May 14, 2019

    Report

    Report Number
    1017294-2019-00053
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    March 15, 2019
    Report Date
    June 17, 2019
    Manufacturer
    CLASSIC WIRE CUT CO, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PREVIOUSLY STATED (B)(4) WAS A SERIAL NUMBER, IT IS CORRECTED TO BE A LOT NUMBER. COMPLAINT WAS CONFIRMED. EXAMINATION OF THE RETURNED USED, DEVICE ITEM TS8850, CONFIRMED THE REPORTED PROBLEM AND FOUND TENDON STRIPPER BROKEN OFF AT THE TIP. THE RETURNED DEVICE WAS INSPECTED AND COULD NOT FIND ANY DISCREPANCIES WITH MACHINED CRITICAL DIMENSIONS. PRODUCT IS MACHINED TO REQUIRED SPECIFICATIONS AND NO SHARP EDGES WERE FOUND WHEN INSPECTED UNDER THE MICROSCOPE. A DEVICE HISTORY RECORD WAS REQUESTED FROM THE MANUFACTURER, CLASSIC WIRE; HOWEVER, THE ONLY INFORMATION PROVIDED WAS THE QUANTITY PRODUCED FOR THE LOT AND THE DATE OF MANUFACTURE. A LOT HISTORY REPORT REVEALED THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS LOT OF PRODUCT PER A TWO-YEAR REVIEW OF COMPLAINT HISTORY. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN 1 COMPLAINT REGARDING 1 DEVICE FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME 386 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED, THE RATE OF FAILURE WOULD BE .003 PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; INSPECT INSTRUMENT PRIOR TO USE TO ENSURE IT IS IN GOOD PHYSICAL CONDITION AND FUNCTIONS PROPERLY. THERE SHOULD BE NO LOOSE, BROKEN OR MISALIGNED PARTS. EXERCISE CARE IN THE USE OF THE DEVICE TO MINIMIZE SIDE OR BENDING LOADS. DO NOT USE EXCESSIVE FORCE ON INSTRUMENTS TO AVOID DAMAGE OR BREAKAGE DURING USE. AVOID UNINTENDED CONTACT WITH OTHER SURGICAL INSTRUMENTS DURING USE TO PREVENT DAMAGE OR BREAKAGE. INSPECT INSTRUMENT AFTER USE TO ENSURE IT HAS NOT BEEN DAMAGED. THIS INSTRUMENT IS DESIGNED FOR USE BY SURGEONS EXPERIENCED IN THE APPROPRIATE SPECIALIZED PROCEDURES. IT IS THE RESPONSIBILITY OF THE SURGEON TO BECOME FAMILIAR WITH THE PROPER TECHNIQUES FOR USE. A DETERMINATION FOR FURTHER INVESTIGATION HAS BEEN INITIATED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS BEING RETURNED TO (B)(4) 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.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE TS8850, CONCEPT GRAFIX TENDON STRIPPER, RUPTURED THE MUSCLE DURING AN ACL PROCEDURE ON (B)(6) 2019. ANOTHER TENDON STRIPPER WAS USED TO COMPLETE THE HARVEST. AN ADDITIONAL INCISION WAS MADE NEXT TO THE ORIGINAL INCISION TO REMOVE THE MUSCLE FROM THE STRIPPER. THE TENDON WAS ABLE TO BE USED AND THE PROCEDURE WAS COMPLETED AS PLANNED EVEN THOUGH THEY DID NOT FEEL THE QUALITY OF THE GRAFT WAS AS GOOD AS IT SHOULD HAVE BEEN. THERE WAS A REPORTED 20-MINUTE DELAY DURING THE PROCEDURE. THIS REPORT IS BEING RAISED BASED ON PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402835 CONCEPT GRAFIX TENDON STRIPPER 7.0MM TENDON STRIPPER LXH CLASSIC WIRE CUT CO, INC 36395

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other