BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPRO

    MDR report key: 20309685 · Received September 26, 2024

    Report

    Report Number
    1017294-2024-00109
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 9, 2024
    Report Date
    October 31, 2024
    Manufacturer
    CONMED LARGO
    Product Code
    HWE
    UDI-DI
    10845854028605
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED; THEREFORE, A DEVICE MALFUNCTION CANNOT BE VERIFIED. THE SERVICE HISTORY WAS REVIEWED, AND NO RELATIONSHIP TO THIS COMPLAINT WAS FOUND. ADDITIONALLY, THE DEVICE WAS PREVIOUSLY SERVICED IN (B)(6) 2020. AS THE SERVICE INTERVAL FOR THIS DEVICE IS 24 MONTHS, THE PM WAS OVERDUE AT THE TIME OF THE COMPLAINT. 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. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF (B)(4) REPORTS, REGARDING (B)(4) 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: PRIOR TO EACH USE, INSPECT ALL EQUIPMENT FOR PROPER OPERATION AND ENSURE ALL ATTACHMENTS AND ACCESSORIES ARE CORRECTLY AND COMPLETELY ATTACHED TO THE HANDPIECE. REAMING AND SAW ATTACHMENTS ARE NOT DESIGNED TO BE USED IN ANY SCREW, TAP OR OSCILLATE DRILL MODES. THEY ARE ONLY TO BE OPERATED IN THE DRILL/REAM MODE. ADDITIONALLY, FAILURE TO FOLLOW THE MAINTENANCE SCHEDULE COULD RESULT IN REDUCED INSTRUMENT PERFORMANCE OR OVERHEATING OF THE HANDPIECE OR ATTACHMENT. IN ADDITION, HEAVY USE OF THE HANDPIECE EXCEEDING THE RECOMMENDED DUTY CYCLE CAN CAUSE THE HANDPIECE OR ATTACHMENT TO OVERHEAT. OVERHEATING CAN LEAD TO POSSIBLE BURN INJURY TO THE PATIENT OR MEDICAL PERSONNEL. ROTATION OF HANDPIECE AND ATTACHMENT USAGE PER DAY WILL ASSIST WITH PROPER PERFORMANCE. 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 PRO6045, HALL SURGICAL POWERPRO RECIPROCATING SAW ATTACHMENT WAS BEING USED ON 9SEP2024 AND ¿THE INCIDENTS HAPPENED DURING A POWER TRIAL, 2 TOTAL HIP SURGERIES. THE ATTACHMENT (PRO6045) DETACHED FROM THE HAND PIECE 2 TIMES¿THE ATTACHMENT DETACHED WHEN IT WAS PUT UNDER PRESSURE, DURING THE CUT WHEN REMOVING CAPUT. NO HARM CAME TO THE STAFF OR PATIENT.". PER FURTHER ASSESSMENT IT WAS FOUND THAT "THE ATTACHMENT DETACHED WHEN IT WAS USED TO CUT COLLUM DURING A TOTAL HIP SURGERY. SO, THE PRO6045 WITH SAWBLADE (5052-261) AS IN THE WOUND WHEN IT CAME OFF. IT HAPPENED 2 TIMES DURING THIS STEP AT THE FIRST SURGERY, BUT THE SURGEON WAS ABLE TO REATTACH IT TO THE HANDPIECE AND COMPLETE THE CUT. ¿THE PRO6045 CAME OFF IN ONE PIECE. NO COMPONENTS FELL OFF FROM THE PRO6045 ITSELF OR THE PRO9200B.". THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. THERE WAS A MINUTE DELAY. THE PRO9200B, HALL TITAN DUAL TRIGGER BATTERY HANDPIECE WILL BE LISTED AS A CONCOMITANT DEVICE AND THERE WAS NO ALLEGATION AGAINST IT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PRO6045, HALL SURGICAL POWERPRO RECIPROCATING SAW ATTACHMENT WAS BEING USED ON (B)(6)2024 AND ¿THE INCIDENTS WHAPPENED DURING A POWER TRIAL, (B)(4) TOTAL HIP SURGERIES. THE ATTACHMENT (PRO6045) DETACHED FROM THE HAND PIECE (B)(4) TIMES¿THE ATTACHMENT DETACHED WHEN IT WAS PUT UNDER PRESSURE, DURING THE CUT WHEN REMOVING CAPUT. NO HARM CAME TO THE STAFF OR PATIENT.". PER FURTHER ASSESSMENT IT WAS FOUND THAT "THE ATTACHMENT DETACHED WHEN IT WAS USED TO CUT COLLUM DURING A TOTAL HIP SURGERY. SO, THE PRO6045 WITH SAWBLADE (5052-261) AS IN THE WOUND WHEN IT CAME OFF. IT HAPPENED 2 TIMES DURING THIS STEP AT THE FIRST SURGERY, BUT THE SURGEON WAS ABLE TO REATTACH IT TO THE HANDPIECE AND COMPLETE THE CUT. ¿THE PRO6045 CAME OFF IN ONE PIECE. NO COMPONENTS FELL OFF FROM THE PRO6045 ITSELF OR THE PRO9200B.". THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE. THERE WAS A MINUTE DELAY. THE PRO9200B, HALL TITAN DUAL TRIGGER BATTERY HANDPIECE WILL BE LISTED AS A CONCOMITANT DEVICE AND THERE WAS NO ALLEGATION AGAINST IT. 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
    2234974 POWERPRO INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMEN HWE CONMED LARGO 10845854028605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PRO9200B, HALL TITAN DUAL TRIGGER.| PRO9200B, HALL TITAN DUAL TRIGGER.| SAWBLADE (5052-261).| SAWBLADE (5052-261).