BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE

    MDR report key: 11331374 · Received February 16, 2021

    Report

    Report Number
    1017294-2021-00067
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    January 20, 2021
    Report Date
    March 30, 2021
    Manufacturer
    CONMED CORPORATION
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT IS CONFIRMED. THE DEVICE IS NOT BEING RETURNED BUT PHOTOGRAPHIC EVIDENCE WAS PROVIDED THAT CONFIRMED THE REPORTED PROBLEM. 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 TWO COMPLAINTS, REGARDING TWO DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: ALWAYS INSPECT FOR BENT, DULL OR DAMAGED BLADES OR BURS BEFORE EACH USE. DO NOT ATTEMPT TO STRAIGHTEN OR SHARPEN. DO NOT USE IF DAMAGED. 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 DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 00507118100, 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE, LOT NUMBER 1112268 WAS BEING USED BY DR (B)(6) DURING A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 WHEN "THE SURGEON NOTICED THAT THE SERRATED TOOTH WAS CHIPPED OFF." UPON FURTHER ASSESSMENT, IT WAS REPORTED THAT THE BROKEN TOOTH WAS RETRIEVED WITH FORCEPS. THE SURGEON WAS USING THE ANTHEM TKR 4/1 FINISHING GUIDE (SIZE 3) AT THE TIME THE DEVICE TOOTH BROKE OFF. AN ALTERNATE SAME DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO REPORT OF INJURY TO THE 82 YEAR OLD, FEMALE PATIENT. THERE WAS A FIVE MINUTE DELAY. 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
    227757 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA CONMED CORPORATION 1112268

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR ANTHEM TKR 4/1 FINISHING GUIDE (SIZE 3)