BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSCILLATING SAW BLADE 19 X 1.19 X 90MM QTY 5

    MDR report key: 19530588 · Received June 13, 2024

    Report

    Report Number
    1017294-2024-00073
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    April 23, 2024
    Report Date
    June 13, 2024
    Manufacturer
    CONMED LARGO
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, A DEVICE MALFUNCTION CANNOT BE VERIFIED. A TWO-YEAR LOT HISTORY REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 40 REPORTS, REGARDING 40 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: 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.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE V190-119-90, OSCILLATING SAW BLADE 19 X 1.19 X 90MM QTY 5 WAS BEING USED ON APPROXIMATELY (B)(6) 2024 AND ¿1 TOOTH BREAKING DURING USE BY SURGEON...(1X TOOTH ON FAR RIGHT SIDE SNAPPED OFF).¿. THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT ¿...THE TOOTH WAS NOT FOUND. IT CANNOT BE CONFIRMED IF THE TOOTH WAS IN THE PATIENT OR DRAPES. X-RAY WAS NOT CALLED AS DISCUSSION AND DECISION BY BOTH SURGEONS WAS THE PIECE WOULD LIKELY BE TOO SMALL TO SEE CLEARLY. AMPLE IRRIGATION OF THE JOINT WAS GIVEN TO ATTEMPT TO FLUSH THE PIECE OUT.¿. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF FRAGMENTATION, ALTHOUGH NOT FOUND IN THE PATIENT, THEY CANNOT PRODUCE THE PIECE AND ITS LOCATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124863 OSCILLATING SAW BLADE 19 X 1.19 X 90MM QTY 5 BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA CONMED LARGO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other