BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHRO TISSLIB BLADE UP *EA

    MDR report key: 7847997 · Received September 5, 2018

    Report

    Report Number
    1221934-2018-54599
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    February 20, 2015
    Report Date
    February 20, 2015
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    NBH
    UDI-DI
    10886705004065
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EVALUATION STATEMENT: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION CONFIRMS THE DEVICE IS BROKEN INTO TWO PIECES, SEPARATED AT THE SHAFT-HANDLE INTERFACE. THE DEVICE APPEARS WORN; THE COLOR OF THE HANDLE IS FADED AND THE LASER ETCH ON THE SHAFT IS SLIGHTLY FADED. THIS FAILURE CAN BE ATTRIBUTED TO THE USER TECHNIQUE WHERE EXCESSIVE FORCE WAS APPLIED ON THE DEVICE CAUSING IT TO BREAK. A BATCH RECORD REVIEW HAS BEEN CONDUCTED FOR THIS LOT OF 24 PIECES THAT WERE MANUFACTURED IN 2013 AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED ONE DIS-SIMILAR COMPLAINT FOR THIS LOT. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE DURING A SHOULDER REPAIR THE CUSTOMER'S TISSUE LIBERATOR BLADE UP BROKE IN HALF WHILE IN THE PATIENT. THE SURGEON REMOVED ALL THE PIECES AND NO X-RAYS WERE DONE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. ADDITIONAL INFORMATION RECEIVED BY MITEK COMPLAINTS ON (B)(6) 2015: THE SALES REP CONFIRMED THAT THE DEVICE BROKE WHERE THE HANDLE MEETS THE METAL SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689857 ARTHRO TISSLIB BLADE UP *EA ORTHOPAEDIC KNIFE NBH DEPUY MITEK LLC US 13C02 10886705004065

    Patients

    Seq Age Sex Outcome Treatment
    1