BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK FMS ULTRA AGGRESSIVE CUTTER 4.0

    MDR report key: 3223725 · Received July 12, 2013

    Report

    Report Number
    1221934-2013-00179
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 10, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    PMA / PMN Number
    K954465
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED BY THE QUALITY ENGINEERING DEPARTMENT. IN REVIEWING THE COMPLAINT DEVICE IT WAS OBSERVED THAT A TOOTH ON THE BROKEN PORTION OF THE BLADE HAD BEEN ¿FOLDED¿ BACKWARDS INDICATING THAT IT HAD IMPACTED SOMETHING HARD (I.E. OTHER SURGICAL INSTRUMENTATION) DURING USE. THIS IMPACT CAUSED THE DEVICE TIP TO SHEER OFF. THE BLADES ARE DESIGNED ONLY TO CUT SOFT TISSUE AND SHOULD NOT BE COMING INTO CONTACT WITH ANY HARD OBJECTS. 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 AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. ALSO, 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.

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT. AWAITING RETURN.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE, A PORTION OF THE DISTAL END OF AN FMS ULTRA AGGRESSIVE CUTTER BROKE OFF INTO THE PATIENT¿S JOINT SPACE. THE FRAGMENT WAS RETRIEVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. HOWEVER, THE PROCEDURE WAS DELAYED BY MORE THAN 30 MINUTES BECAUSE OF THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321555 MITEK FMS ULTRA AGGRESSIVE CUTTER 4.0 ARTHROSCOPIC INSTRUMENT HRX DEPUY MITEK NA M1209017

    Patients

    Seq Age Sex Outcome Treatment
    1