BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING SAW BLADE 19 X 1.19 X 90MM QTY 5

    MDR report key: 19530531 · Received June 13, 2024

    Report

    Report Number
    1017294-2024-00072
    Event Type
    Malfunction
    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
    Product Problem
    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) 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 (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 23APR24 AND THE ¿DURING USE BY SURGEON...THE COLLET PIECE BROKE ¿ THIS WAS RETRIEVED AND DISCARDED.¿. THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT. 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
    803504 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