BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARREL BURR PLUS, 4.0MM CROSSCUT MICRO HUB

    MDR report key: 7753845 · Received August 6, 2018

    Report

    Report Number
    1221934-2018-53632
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    May 4, 2015
    Report Date
    May 4, 2015
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705022045
    PMA / PMN Number
    K041824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION STATEMENT THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION REVEALS THE PROXIMAL END OF THE DEVICE IS BROKEN AS REPORTED. THIS COMPLAINT CAN BE CONFIRMED. IT WAS REPORTED THAT THE USER WAS PUTTING A LARGE AMOUNT OF TORQUE ON THE HAND PIECE/BURR WHICH IS LIKELY WHAT CAUSED THE HAND PIECE TO WARM UP AND THE BURR TO BREAK. THIS FAILURE CAN BE ATTRIBUTED TO DEVICE MISHANDLING AND USER TECHNIQUE. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AS RELATED THE REPORTED PROBLEM, AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. THIS REPORT IS BEING FILED FROM THE REMETREX COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS USING THE BURR ON A SUB-ACHROMIAL DECOMPRESSION TO BURR THE UNDERSIDE OF THE ACHROMION IN A SHOULDER SCOPE CASE ON (B)(6) 2015 . HE COMMENTED THAT THE FMS MICRO TORNADO HAND PIECE STARTED TO FEEL WARM. MOMENTS LATER THE PLASTIC BASE PORTION THAT CONNECTS INTO THE HAND PIECE BROKE. HE COMMENTED THAT HE WAS PUTTING A LARGE AMOUNT OF TORQUE ON THE HAND PIECE/ BURR CONSTRUCT WHICH IS LIKELY WHAT CAUSED THE HAND PIECE TO WARM UP AND THE BURR TO BREAK. THE BROKEN PIECE FELL OFF OUTSIDE THE PATIENT SO THERE ARE NO CONCERNS FOR LOST PIECES IN THE PATIENT. WE OPENED ANOTHER BURR WHICH WORKED FINE FOR THE REMAINDER OF THE SAD AND DISTAL CLAVICLE EXCISION. THE HAND PIECE ALSO DID NOT HEAT UP AFTER THAT NEW BURR WAS INSTALLED AND HE DIDN¿T STRESS THE CONSTRUCT WITH HIGHER TORQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594172 BARREL BURR PLUS, 4.0MM CROSSCUT MICRO HUB  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE HRX DEPUY MITEK LLC US M1405022 10886705022045

    Patients

    Seq Age Sex Outcome Treatment
    1