BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM STERLING LIGHTNING BUR

    MDR report key: 7948643 · Received October 9, 2018

    Report

    Report Number
    1017294-2018-00159
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    July 24, 2018
    Report Date
    October 9, 2018
    Manufacturer
    CONMED CORPORATION
    Product Code
    GFF
    UDI-DI
    10845854029671
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, ROOT CAUSE CANNOT BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY REPORT FOUND NO ANOMALIES THAT WOULD CONTRIBUTE TO THIS ISSUE. A 2 YEAR REVIEW OF COMPLAINT HISTORY REVEALED A TOTAL OF 46 REPORTS WITH A QUANTITY OF 53 DEVICES RELATED TO THIS DEVICE FAMILY AND FAILURE MODE. DURING THE 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; DO NOT USE EQUIPMENT IF UPON RECEIPT, PACKAGE IS OPENED, DAMAGED, OR SHOWS SIGNS OF TAMPERING. CONTINUALLY CHECK FOR OVERHEATING, IF OVERHEATING IS SENSED IMMEDIATELY DISCONTINUE USE. DO NOT USE BURS FOR PLUNGE CUTTING. INJURY OR DAMAGE COULD OCCUR. DO NOT USE SHAVER BUR IF THEY SHOW ANY SIGNS OF DAMAGE. INSPECT FOR BENT, DULL, OR DAMAGED BLADES AND BURS BEFORE EACH USE. DO NOT APPLY EXCESSIVE LOADING/FORCE ON THE SHAVER BLADE OR BUR. DIRECT CONTACT OF THE ROTATING CUTTING EDGE OF SHAVER BLADES AND BURS WITH METALLIC SURFACES AND/OR OTHER HARD SURFACES SUCH AS ARTHROSCOPES, CANNULAS, OR OTHER INSTRUMENTS CAN CAUSE DAMAGE TO THE DEVICES, SHAVER BLADE OR BUR SHOULD BE EXAMINED FOR DAMAGE AND REPLACED IF NECESSARY. A DETERMINATION FOR FURTHER INVESTIGATION HAS BEEN INITIATED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CONMED REPRESENTATIVE REPORTED THAT THE INNER CUTTING BLADE DETACHED FROM INNER HUB AND WOULD NOT SPIN. NO INJURY TO THE PATIENT IS REPORTED. THIS REPORT IS BEING RAISED BASED ON A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788053 4.5MM STERLING LIGHTNING BUR ARTHROSCOPIC BUR/SHAVER GFF CONMED CORPORATION 942414 10845854029671

    Patients

    Seq Age Sex Outcome Treatment
    1