BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK EXPRESSEW III NEEDLE

    MDR report key: 3102973 · Received May 9, 2013

    Report

    Report Number
    1221934-2013-00131
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 6, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SEVENTY DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO MITEK, AND TO DATE, DESPITE OUTREACHES FOR FURTHER DETAIL AND COMPLAINT DEVICE RETURN, NOTHING HAS BEEN RECEIVED, AND NO ADDITIONAL INFORMATION OTHER THAN WHAT WAS ORIGINALLY REPORTED HAS BEEN RECEIVED. 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 COMPLAINTS OF ANY KIND FOR THIS LOT OF XXX DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED ISSUE. 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. DEVICE EVALUATED BY MFR: AWAITING RETURN.

    Description of Event or Problem · 1

    THE USER FACILITY IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, A PORTION OF THE DISTAL TIPS OF A MITEK EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLES BROKE OFF INTO THE PATIENT'S JOINT SPACE. THEY WERE NOT ABLE TO LOCATE THE FRAGMENT; HOWEVER, THE REPAIR WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203995 MITEK EXPRESSEW III NEEDLE ARTHROSCOPIC INSTRUMENT LXH DEPUY MITEK NA A302010

    Patients

    Seq Age Sex Outcome Treatment
    1