BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALL TITAN PRIMECUT+

    MDR report key: 20191174 · Received September 11, 2024

    Report

    Report Number
    1017294-2024-00105
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    August 28, 2024
    Report Date
    October 29, 2024
    Manufacturer
    CONMED LARGO
    Product Code
    HAB
    UDI-DI
    40845854050805
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE REPORTED PROBLEM. ADDITIONAL PROBLEMS FOUND THAT THE BLADE CONTACTS ARE WORN/DAMAGED AND THE OSCILLATOR HEAD ASSEMBLY IS LEAKING. THE UNIT WAS REPAIRED, EVALUATION COMPLETED AND FINAL TESTED. THE UNIT MET ALL SPECIFICATIONS. THE PREVENTIVE MAINTENANCE WAS OVERDUE. 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. THE SERVICE HISTORY WAS REVIEWED, AND NO PRIOR DATA WAS FOUND. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 68 REPORTS, REGARDING 68 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: FAILURE TO FOLLOW THE 12-MONTH SERVICE INTERVAL COULD RESULT IN REDUCED INSTRUMENT PERFORMANCE OR OVERHEATING OF THE HANDPIECE. OVERHEATING CAN LEAD TO POSSIBLE BURN INJURY TO THE PATIENT OR MEDICAL PERSONNEL. ROTATION OF HANDPIECE USAGE PER DAY WILL ASSIST WITH PROPER PERFORMANCE. THE HALL TITAN HANDPIECES SHALL BE RETURNED EVERY 12 MONTHS FOR SERVICING. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    A SERVICE REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE (B)(4), HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE DEVICE WAS BEING USED DURING HIP REPLACEMENT SURGERY ON (B)(6) 2024, AND ¿THE SAW FREEZES WHEN AGAINST HARD BONE AND THAT A FRACTURE OCCURRED IN THE SAW WHEN IT FROZE IN THE MIDDLE OF SAWING.¿. FOLLOW-UP ASSESSMENT FOUND THAT "THE FINNISH WORD FOR FRACTURE CAN ALSO BE TRANSLATED AS FAULT, SO NOW WITH MORE INFORMATION THAT IS THE BETTER WORD. NOTHING CAME OFF THE SAW. THE PROBLEM WAS THAT WHEN THE SAW BLADE MADE CONTACT WITH THE BONE, THE MOVEMENT OF THE SAW BLADE STOPPED, I.E. SAWING STOPPED, BUT THE SOUND WAS HEARD. THE SAW HAD TO BE DRAGGED BACK AND FORTH, BECAUSE THE SAWING STOPPED WHEN IT HIT HARDER BONE. AS IF THE SAW DIDN'T HAVE ENOUGH TORQUE TO MOVE THE SAW BLADE. WHEN REMOVING THE CAPUT, IT WAS NOTICED THAT THE NECK HAD NOT BEEN SAWED OFF COMPLETELY, BUT A PIECE OF THE FEMUR BROKE OFF WHEN REMOVING IT (THE CAPUT WAS STILL ATTACHED TO A SMALL PART, WHICH WAS NOT VISIBLE). A SMALL PIECE BROKE FROM THE FEMUR, A DALL-MILES WIRE INSERTED JUST IN CASE. DALL-MILES WIRE PUT IN, SETTLED NORMALLY". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A SMALL PIECE BROKE FROM THE FEMUR AND THE APPLICATION OF A DALL-MILES WIRE. THE TN190-089-90, MCLASS OSCILLATING SAW BLADE 19 X 0.89 (0.035") X 90 MM WILL BE LISTED AS A CONCOMITANT DEVICE; THERE ARE NO ALLEGATIONS REPORTED AGAINST IT.

    Description of Event or Problem · 0

    A SERVICE REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE PRO9350B, HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE DEVICE WAS BEING USED DURING HIP REPLACEMENT SURGERY ON (B)(6) 2024, AND ¿THE SAW FREEZES WHEN AGAINST HARD BONE AND THAT A FRACTURE OCCURRED IN THE SAW WHEN IT FROZE IN THE MIDDLE OF SAWING.¿ FOLLOW-UP ASSESSMENT FOUND THAT "THE FINNISH WORD FOR FRACTURE CAN ALSO BE TRANSLATED AS FAULT, SO NOW WITH MORE INFORMATION THAT IS THE BETTER WORD. NOTHING CAME OFF THE SAW. THE PROBLEM WAS THAT WHEN THE SAW BLADE MADE CONTACT WITH THE BONE, THE MOVEMENT OF THE SAW BLADE STOPPED, I.E. SAWING STOPPED, BUT THE SOUND WAS HEARD. THE SAW HAD TO BE DRAGGED BACK AND FORTH, BECAUSE THE SAWING STOPPED WHEN IT HIT HARDER BONE. AS IF THE SAW DIDN'T HAVE ENOUGH TORQUE TO MOVE THE SAW BLADE. WHEN REMOVING THE CAPUT, IT WAS NOTICED THAT THE NECK HAD NOT BEEN SAWED OFF COMPLETELY, BUT A PIECE OF THE FEMUR BROKE OFF WHEN REMOVING IT (THE CAPUT WAS STILL ATTACHED TO A SMALL PART, WHICH WAS NOT VISIBLE). A SMALL PIECE BROKE FROM THE FEMUR, A DALL-MILES WIRE INSERTED JUST IN CASE. DALL-MILES WIRE PUT IN, SETTLED NORMALLY". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A SMALL PIECE BROKE FROM THE FEMUR AND THE APPLICATION OF A DALL-MILES WIRE. THE TN190-089-90, MCLASS OSCILLATING SAW BLADE 19 X 0.89 (0.035") X 90 MM WILL BE LISTED AS A CONCOMITANT DEVICE; THERE ARE NO ALLEGATIONS REPORTED AGAINST IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587947 HALL TITAN PRIMECUT+ SAW, POWERED, AND ACCESSORIES HAB CONMED LARGO 40845854050805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other TN190-089-90, MCLASS OSCILLATING SAW BLADE.| TN190-089-90, MCLASS OSCILLATING SAW BLADE.