BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALIX ADVANCE BR 4.5 MM, 3 SUTURE W/ORTHOCORD

    MDR report key: 7723738 · Received July 26, 2018

    Report

    Report Number
    1221934-2018-54215
    Event Type
    Malfunction
    Date Received
    July 26, 2018
    Date of Event
    October 24, 2014
    Report Date
    October 28, 2014
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705021321
    PMA / PMN Number
    K120078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. INVESTIGATION SUMMARY: EVALUATION STATEMENT. 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 MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND 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 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. DEVICE HISTORY LOT: THE BATCH REVIEW 3770498 SHOWED THAT THE DEVICES WERE CONFORMED TO IN PROCESS AND FINISHED GOODS SPECIFICATIONS WHEN RELEASED TO STOCK THE 9 MAY 2014. EXPIRATION DATE: 2017-03 (ACCORDING TO RETAINED LABELS). NO NONCONFORMANCE WAS OPENED. THIS REPORT IS BEING FILED FROM THE REMETREX 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

    DURING ARTHROSCOPIC ROTATOR CUFF REPAIR, THE THREAD PART AT THE TIP OF THE PRODUCT WAS BROKEN WHEN INSERTING. THE PRODUCT WAS DISCARDED AT THE HOSPITAL. NO SURGICAL DELAY WAS REPORTED. THE BACKUP DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564446 HEALIX ADVANCE BR 4.5 MM, 3 SUTURE W/ORTHOCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 3770498 10886705021321

    Patients

    Seq Age Sex Outcome Treatment
    1