BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSCILLATING SAW BLADE 19 X 1.27 X 105MM QTY 5

    MDR report key: 16683997 · Received April 5, 2023

    Report

    Report Number
    1017294-2023-00031
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    February 23, 2023
    Report Date
    April 25, 2023
    Manufacturer
    CONMED LARGO
    Product Code
    GFA
    UDI-DI
    10845854021446
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED AND NO PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED; THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. 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 THE FOLLOWING: AVOID CONTACT OF BLADES AND BURS WITH CUTTING BLOCKS, RETRACTORS OR OTHER INSTRUMENTATION. DAMAGE TO THE BLADE, BUR OR INSTRUMENT MAY OCCUR. THE IFU ALSO ADVISES THE USER TO NOT USE SAW BLADES TO PRY, REMOVE BONE GRAFTS OR AS A LEVERAGE POINT; PATIENT OR USER INJURY COULD OCCUR. 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. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    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. 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 V190-127-05 OSCILLATING SAW BLADE 19 X 1.27 X 105MM QTY 5 WAS BEING USED ON (B)(6) 2023 DURING A TOTAL HIP REPLACEMENT PROCEDURE AND ¿THE CUTTING EDGE OF THE BLADE WAS DAMAGED DURING THE FIRST FEMORAL CUT (NEW PACKAGING - ONE CUT).¿ AFTER FURTHER ASSESSMENT IT WAS FOUND THE BLADE DID FRAGMENT (THE LATERAL TOOTH BROKE OFF) AND THE "NURSES DISCOVERED THE SITUATION AT THE END OF THE SURGERY (PATIENT SKIN ALREADY CLOSED). THEY DIDN¿T FIND THE BLADE PIECE, THEY INFORMED THE SURGEON WHO DECIDED TO NO TAKE OTHER ACTIONS." IT IS UNKNOWN IF THE FRAGMENT FELL INTO THE SURGICAL SITE, "THEY ARE NOT SURE BECAUSE THEY DIDN¿T FIND THE FRAGMENTED PIECE ANYMORE. PROBABLY IT FELL OUTSIDE THE SURGICAL SITE, BUT THEY DIDN'T GIVE ME A DEFINITIVE ANSWER. THEY DIDN'T DO RX CONTROL." THE PROCEDURE WAS COMPLETED AND THERE WAS NO DELAY. THE PATIENT WAS REPORTED AS "OK" AND THERE WAS NO MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION REQUIRED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO FRAGMENTATION, ALTHOUGH THEY ARE NOT CERTAIN IT FELL INTO THE SURGICAL SITE, THEY CANNOT PRODUCE THE PIECE AND ITS LOCATION IS UNKNOWN.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE V190-127-05 OSCILLATING SAW BLADE 19 X 1.27 X 105MM QTY 5 WAS BEING USED ON (B)(6 2023 DURING A TOTAL HIP REPLACEMENT PROCEDURE AND ¿THE CUTTING EDGE OF THE BLADE WAS DAMAGED DURING THE FIRST FEMORAL CUT (NEW PACKAGING - ONE CUT).¿. AFTER FURTHER ASSESSMENT IT WAS FOUND THE BLADE DID FRAGMENT (THE LATERAL TOOTH BROKE OFF) AND THE "NURSES DISCOVERED THE SITUATION AT THE END OF THE SURGERY (PATIENT SKIN ALREADY CLOSED). THEY DIDN¿T FIND THE BLADE PIECE, THEY INFORMED THE SURGEON WHO DECIDED TO NO TAKE OTHER ACTIONS." IT IS UNKNOWN IF THE FRAGMENT FELL INTO THE SURGICAL SITE, "THEY ARE NOT SURE BECAUSE THEY DIDN¿T FIND THE FRAGMENTED PIECE ANYMORE. PROBABLY IT FELL OUTSIDE THE SURGICAL SITE, BUT THEY DIDN'T GIVE ME A DEFINITIVE ANSWER. THEY DIDN'T DO RX CONTROL.". THE PROCEDURE WAS COMPLETED AND THERE WAS NO DELAY. THE PATIENT WAS REPORTED AS "OK" AND THERE WAS NO MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION REQUIRED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO FRAGMENTATION, ALTHOUGH THEY ARE NOT CERTAIN IT FELL INTO THE SURGICAL SITE, THEY CANNOT PRODUCE THE PIECE AND ITS LOCATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258471 OSCILLATING SAW BLADE 19 X 1.27 X 105MM QTY 5 BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA CONMED LARGO V190-127-05 1280908 10845854021446

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other