BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK EXPRESSEW III NEEDLE

    MDR report key: 2854690 · Received December 3, 2012

    Report

    Report Number
    1221934-2012-00324
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    MITEK RECEIVED 10 EXPRESSEW III NEEDLES, PART # 214141 / LOT # A207035 NEW AND STILL PACKAGED. THE DEVICES WERE 1ST OF ALL UNPACKAGED AND VISUALLY EXAMINED UNDER 10X MAGNIFICATION; THE DEVICES APPEAR IN THE AS DESIGNED AND MANUFACTURED CONDITION, NO DAMAGE AND NO APPARENT ANOMALIES. EACH OF THE 10 DEVICES WERE LOADED INTO AN EXPRESSEW TEST GUN AND FIRED 20 TIMES WITHOUT ISSUE. WE COULD FIND NO FAULT WITH THESE DEVICES. 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 ONE OTHER SIMILAR COMPLAINT FOR THIS LOT OF 2,995 DEVICES THAT WERE RELEASED TO DISTRIBUTION; THIS OTHER COMPLAINT IS ASSOCIATED WITH THIS ISSUE (SEE 1221934-2012-00326), SAME FACILITY AND SURGEON. WE CANNOT CONCLUDE AS TO WHAT MAY HAVE CAUSED THE NEEDLE TO BREAK. HOWEVER, HISTORICALLY, THIS TYPE OF FAILURE HAS BEEN ATTRIBUTED TO THE POSSIBILITY THAT THE USER MAY HAVE HIT BONE OR SOME OTHER OBJECT WHEN DEPLOYING THE NEEDLE THROUGH THE SOFT TISSUE CAUSING THE DISTAL PORTION OF THE NEEDLE TO POSSIBLY FATIGUE AND BREAK OFF. ALSO, THIS IS A SINGLE USE DEVICE, AND IT WAS NOT ESTABLISHED THAT THE DEVICE WAS USED ONLY ONCE, WHICH COULD HAVE LED TO THIS PARTICULAR FAILURE MODE AS WELL. OUTSIDE OF THESE HYPOTHESES AND CONSIDERATION, NO CONCLUSIONS CAN BE DRAWN. AT THIS POINT IN TIME NO CORRECTIVE OR FURTHER ACTION IS NECESSARY, HOWEVER, 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 RECEIVED 10 EXPRESSEW III NEEDLES, PART # 214141 / LOT # A207035 NEW AND STILL PACKAGED. THE DEVICES WERE 1ST OF ALL UNPACKAGED AND VISUALLY EXAMINED UNDER 10X MAGNIFICATION; THE DEVICES APPEAR IN THE AS DESIGNED AND MANUFACTURED CONDITION, NO DAMAGE AND NO APPARENT ANOMALIES. EACH OF THE 10 DEVICES WERE LOADED INTO AN EXPRESSEW TEST GUN AND FIRED 20 TIMES WITHOUT ISSUE. WE COULD FIND NO FAULT WITH THESE DEVICES. 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 ONE OTHER SIMILAR COMPLAINT FOR THIS LOT OF 2,995 DEVICES THAT WERE RELEASED TO DISTRIBUTION; THIS OTHER COMPLAINT IS ASSOCIATED WITH THIS ISSUE (SEE 1221934-2012-00325), SAME FACILITY AND SURGEON. WE CANNOT CONCLUDE AS TO WHAT MAY HAVE CAUSED THE NEEDLE TO BREAK. HOWEVER, HISTORICALLY, THIS TYPE OF FAILURE HAS BEEN ATTRIBUTED TO THE POSSIBILITY THAT THE USER MAY HAVE HIT BONE OR SOME OTHER OBJECT WHEN DEPLOYING THE NEEDLE THROUGH THE SOFT TISSUE CAUSING THE DISTAL PORTION OF THE NEEDLE TO POSSIBLY FATIGUE AND BREAK OFF. ALSO, THIS IS A SINGLE USE DEVICE, AND IT WAS NOT ESTABLISHED THAT THE DEVICE WAS USED ONLY ONCE, WHICH COULD HAVE LED TO THIS PARTICULAR FAILURE MODE AS WELL. OUTSIDE OF THESE HYPOTHESES AND CONSIDERATION, NO CONCLUSIONS CAN BE DRAWN. AT THIS POINT IN TIME NO CORRECTIVE OR FURTHER ACTION IS NECESSARY, HOWEVER, 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.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT DURING A ARTHROSCOPIC SHOULDER REPAIR, A PORTION OF THE DISTAL TIP OF AN EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLE BROKE OFF INTO THE BODY. THE FRAGMENT WAS EASILY RETRIEVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK EXPRESSEW III NEEDLE ARTHROSCOPIC INSTRUMENT LXH DEPUY MITEK NA A207035

    Patients

    Seq Age Sex Outcome Treatment
    1