BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK EXPRESSEW III NEEDLE

    MDR report key: 3102392 · Received May 9, 2013

    Report

    Report Number
    1221934-2013-00129
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 7, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    70 DAYS HAVE PASSED SINCE THIS ISSUE WAS FIRST REPORTED TO MITEK. THE COMPLAINT DEVICE IS NOT BEING RETURNED, WHICH PRECLUDES CONDUCTING AN EVALUATION; HOWEVER, 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 (B)(4) DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT TELL ANYTHING FROM THIS; WE CANNOT DISCERN A ROOT OR UNDERLYING CAUSE FOR THE REPORTED FAILURE MODE. 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.

    Description of Event or Problem · 1

    MITEK RECEIVED A MEDWATCH REPORT FROM THE USER FACILITY WHICH DESCRIBES A MITEK EXPRESSEW III FLEXIBLE SUTURE PASSER NEEDLE HAVING A PORTION OF ITS DISTAL END BREAK OFF INTO THE BODY DURING AN ARTHROSCOPIC SHOULDER REPAIR. THE FRAGMENT WAS NOT ABLE TO BE RETRIEVED; HOWEVER, [THE FOLLOWING IS PER TELEPHONE FOLLOW-UP CONVERSATION WITH THE FACILITY'S RISK MANAGER. AS (B)(6) 2013,] THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204171 MITEK EXPRESSEW III NEEDLE ARTHROSCOPIC INSTRUMENT LXH DEPUY MITEK NA A301017

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR