BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOCORDVIOLET W/MO-6 NDLS PK/12

    MDR report key: 7899249 · Received September 21, 2018

    Report

    Report Number
    1221934-2018-52408
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Report Date
    August 30, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    NEW
    UDI-DI
    10886705008735
    PMA / PMN Number
    K040004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE COMPLAINT DEVICE IS NOT BEING RETURNED, 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 SYNTHES MITEK COMPLAINTS SYSTEM REVEALED 1 OTHER SIMILAR COMPLAINT FOR THIS LOT OF DEVICES 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 SYNTHES 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. THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREAD BROKE BY FRAYING DURING TRACTION. INCIDENT DIFFICULT TO CATCH. PROCEDURE HAS BEEN EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740796 ORTHOCORDVIOLET W/MO-6 NDLS PK/12 POLYDIOXANONE SUTURE NEW DEPUY MITEK LLC US JK2380 10886705008735

    Patients

    Seq Age Sex Outcome Treatment
    1