BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOCORD SUTURE (ABSORBABLE) WITH NEEDLES

    MDR report key: 1942063 · Received November 9, 2010

    Report

    Report Number
    1221934-2010-00424
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    NEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS REPORTED THAT THERE IS NO PT CONSEQUENCE, THE FRAGMENT WAS NOT RETRIEVED FROM THE PT'S BODY. WE DO NOT KNOW WHAT IMPACT, IF ANY, THIS WOULD HAVE ON THE PT. IT IS BECAUSE OF THIS UNCERTAINTY THAT THIS REPORT IS BEING FILED TO DOCUMENT THIS EVENT. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE, IS UNAVAILABLE FOR A PHYSICAL EVAL. 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 NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF 2,172 DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. BASED ON COMPLAINT RATE AND CUSTOMER IMPACT, WE BELIEVE THIS TO BE AN ANOMALY. 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

    OUR SALES REP REPORTED THE TIP OF A NEEDLE BROKE OFF INTO THE PT'S INCISION DURING A SHOULDER PROCEDURE. THE SURGEON WAS NOT ABLE TO LOCATE THE BROKEN PIECE OF NEEDLE IN THE PT. THE SALES REP STATED THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF ANY HARM OR CONSEQUENCE TO THE PT. THE COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOCORD SUTURE (ABSORBABLE) WITH NEEDLES SUTURE WITH NEEDLES NEW DEPUY MITEK 223104 CJ2585

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK