BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING SAW BLADE 19 X 1.19 X 105MM QTY 5

    MDR report key: 19276748 · Received May 9, 2024

    Report

    Report Number
    1017294-2024-00052
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 10, 2024
    Report Date
    June 24, 2024
    Manufacturer
    CONMED LARGO
    Product Code
    GFA
    UDI-DI
    10845854021422
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF RETURNED USED BLADE, ITEM V190-119-05 FOUND BROKEN TEETH AND DAMAGED BLADE SURFACE. A BROKEN TOOTH WAS NOT RETURNED FOR EVALUATION. EXAMINATION WAS PERFORMED PER PRINT V190-119-05 COULD NOT FIND ANY ISSUE WITH CRITICAL DIMENSIONS. ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, BASED UPON EVALUATION OF THE DEVICE; A POSSIBLE CAUSE OF THIS EVENT COULD BE EXCESSIVE FORCE. 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. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT WHEN USING THE POWERPRO SAGITTAL SAW ATTACHMENT (PRO2043), PLACING EXCESSIVE BENDING OR TWISTING FORCE ON THE SAGITTAL SAW BLADE MAY CAUSE THE COLLET TO OPEN AND RELEASE THE SAW BLADE. DO NOT USE SAW BLADES TO PRY, REMOVE BONE GRAFTS, OR AS A LEVERAGE POINT. PATIENT OR USER INJURY COULD OCCUR. WHEN OPERATING THE POWERPRO ELECTRIC II OSCILLATOR HANDPIECE, LET THE SAW BLADE DO THE CUTTING. TOO MUCH FORCE WILL BIND THE BLADE WHICH CAN DAMAGE THE HANDPIECE. 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. H3 OTHER TEXT : DEVICE NOT YET RECEIVED.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE V190-119-05, OSCILLATING SAW BLADE 19 X 1.19 X 105MM QTY 5, WAS BEING USED DURING A KNEE TEP PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿A TOOTH OF THE SAW BLADE BROKE OFF DURING THE SAWING PROCESS.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONS WERE ASKED AND IT WAS DISCOVERED THAT THE TOOTH OF THE SAW BLADE BROKE OFF AND AFTER A SHORT SEARCH IT WAS RECOVERED FROM THE OPERATING FIELD USING A CLAMP. IT IS UNKNOWN IF THE FRAGMENTATION HAD BEEN IN CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER SAME DEVICE WHICH CAUSED A 5-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE. UPDATE: ADDITIONAL INFORMATION RECEIVED 13MAY2024 STATES, "YES THE FRAGMENT WAS IN THE PATIENT AND COULD BE SECURED."

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE V190-119-05, OSCILLATING SAW BLADE 19 X 1.19 X 105MM QTY 5, WAS BEING USED DURING A KNEE TEP PROCEDURE ON (B)(6) 24 WHEN IT WAS REPORTED, ¿A TOOTH OF THE SAW BLADE BROKE OFF DURING THE SAWING PROCESS.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONS WERE ASKED AND IT WAS DISCOVERED THAT THE TOOTH OF THE SAW BLADE BROKE OFF AND AFTER A SHORT SEARCH IT WAS RECOVERED FROM THE OPERATING FIELD USING A CLAMP. IT IS UNKNOWN IF THE FRAGMENTATION HAD BEEN IN CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER SAME DEVICE WHICH CAUSED A 5-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359090 OSCILLATING SAW BLADE 19 X 1.19 X 105MM QTY 5 BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA CONMED LARGO 1301834 10845854021422

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female