BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNUM SAW HANDPIECE

    MDR report key: 15690575 · Received October 28, 2022

    Report

    Report Number
    1017294-2022-00102
    Event Type
    Injury
    Date Received
    October 28, 2022
    Date of Event
    October 4, 2022
    Report Date
    December 7, 2022
    Manufacturer
    CONMED LARGO
    Product Code
    KFK
    PMA / PMN Number
    K801737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS BEEN RETURNED TO CONMED; HOWEVER, THE EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT, ¿SAW BLADE GUARD BECAME DETACHED AND THE SURGEON ENDED UP WITH SERIOUS DAMAGE TO HIS HAND¿, IS UNCONFIRMED BASED ON DEVICE EVALUATION. EVALUATION COULD NOT CONFIRM THE REPORTED COMPLAINT. UNABLE TO REPLICATE FAULT OF SAW GUARD COMING LOOSE. COLLET AND GUARD BOTH FUNCTION CORRECTLY. PREVENTATIVE MAINTENANCE IS OVERDUE. ADDITIONAL PROBLEMS FOUND WERE TRIGGER STICKING/SEIZED, MOTOR ¿ LOW SPEED/TORQUE. A DEVICE HISTORY RECORD REVIEW WAS NOT CONDUCTED AS THE DEVICE HAS BEEN IN THE FIELD GREATER THAN 12 MONTHS. THE SERVICE HISTORY WAS REVIEWED, AND NO PRIOR RELATIONSHIP TO THIS COMPLAINT WAS FOUND. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 5 REPORTS, REGARDING 5 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: REGULAR AND PROPER MAINTENANCE OF YOUR HALL STERNUM SAW ARE THE BEST WAYS TO PROTECT YOUR INVESTMENT. IT IS ESSENTIAL THAT YOU HAVE YOUR HALL STERNUM SAW SERVICED EVERY TWELVE (12) MONTHS SO AS TO RETAIN ITS OPTIMUM PERFORMANCE AND RELIABILITY, WHICH WILL REWARD YOU WITH SAFER, LESS PROBLEMATIC PRODUCT PERFORMANCE OVER TIME. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, 00505900500, STERNUM SAW HANDPIECE WAS BEING USED ON APPROXIMATELY (B)(6) 2022 AND ¿HAS BEEN INVOLVED IN AN INCIDENT AND THE SAW BLADE GUARD BECAME DETACHED AND THE SURGEON ENDED UP WITH SERIOUS DAMAGE TO HIS HAND. I HAVE CHECKED AND CAN¿T SEE ANY OBVIOUS FAULT.¿ A GOOD FAITH EFFORT WAS MADE TO OBTAIN MORE INFORMATION, BUT TO DATE, NO OTHER INFORMATION HAS BEEN RECEIVED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO DAMAGE TO SURGEON¿S HAND.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE, 00505900500, STERNUM SAW HANDPIECE WAS BEING USED ON APPROXIMATELY (B)(6) 2022 AND ¿HAS BEEN INVOLVED IN AN INCIDENT AND THE SAW BLADE GUARD BECAME DETACHED AND THE SURGEON ENDED UP WITH SERIOUS DAMAGE TO HIS HAND. I HAVE CHECKED AND CAN¿T SEE ANY OBVIOUS FAULT.¿ A GOOD FAITH EFFORT WAS MADE TO OBTAIN MORE INFORMATION, BUT TO DATE, NO OTHER INFORMATION HAS BEEN RECEIVED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO DAMAGE TO SURGEON¿S HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2854165 STERNUM SAW HANDPIECE SAW, PNEUMATICALLY POWERED KFK CONMED LARGO 10978

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other