BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK EXPRESSEW III NEEDLE

    MDR report key: 3790887 · Received May 5, 2014

    Report

    Report Number
    1221934-2014-00169
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED; IT WAS DISCARDED BY THE CUSTOMER AND THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. 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 DEPUY MITEK COMPLAINTS SYSTEM REVEALED ONE OTHER SIMILAR COMPLAINT AND ONE OTHER DISSIMILAR COMPLAINT FOR THIS LOT OF 2,995 NEEDLES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. 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.

    Description of Event or Problem · 1

    THE SALES REP REPORTED ONE OF THE CUSTOMER'S EXPRESSEW III NEEDLES BROKE AT THE DISTAL TIP WHILE PASSING SUTURE IN THE SHOULDER DURING A ROTATOR CUFF PROCEDURE. HE STATED THE DISTAL TIP BROKE OFF AFTER THE SURGEON HAD PASSED SUTURE ABOUT 5 OR 6 TIMES. THE SURGEON WAS NOT ABLE TO FIND THE BROKEN TIP OF THE NEEDLE AND AN X-RAY WAS DONE HOWEVER IT DID NOT REVEAL THE LOCATION OF THE FRAGMENT. THE PROCEDURE WAS DELAYED FOR LESS THAN 2 MINUTES DUE TO THE NEEDLE BREAKING. THE SURGEON COMPLETED THE PROCEDURE USING ANOTHER NEEDLE WITH NO FURTHER HARM OR CONSEQUENCE TO THE PATIENT. THE COMPLAINT DEVICE NEEDLE WAS DISCARDED BY THE CUSTOMER. NO FURTHER DETAILS COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267328 MITEK EXPRESSEW III NEEDLE ARTHROSCOPIC SUTURING NEEDLE LXH DEPUY MITEK NA A304002

    Patients

    Seq Age Sex Outcome Treatment
    1