BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.75 HEALIX ADVANCE KNTLSS BR

    MDR report key: 8284661 · Received January 29, 2019

    Report

    Report Number
    1221934-2019-56196
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    April 20, 2016
    Report Date
    April 21, 2016
    Manufacturer
    A DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COND
    Product Code
    MAI
    UDI-DI
    10886705023462
    PMA / PMN Number
    K130917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4). THE EXP DATE IS CURRENTLY UNAVAILABLE. 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 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 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. A NON-CONFORMANCE SEARCH WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED FOR THE PAT/LOT NUMBER COMBINATION. THIS REPORT IS BEING FILED FROM THE (B)(4) 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 BY THE AFFILIATE IN (B)(6) THAT DURING ARTHROSCOPIC ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THE 4.75 HEALIX ADVANCE KNTLSS BR DEVICE BROKE DURING INSERTION INTO A BONE HOLE. THE DEVICE WAS DISCARDED AT THE HOSPITAL. IT WAS ALSO REPORTED THAT NO BROKEN PIECE WAS LEFT IN THE PATIENT¿S BODY. THERE WAS NO SURGICAL DELAY OR HARM TO THE PATIENT. THE SALES REP HAS PROVIDED THE INSTRUCTION OF THIS DEVICE TO THE SURGEON. THE BACKUP DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80012 4.75 HEALIX ADVANCE KNTLSS BR SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI A DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COND 3875849 10886705023462

    Patients

    Seq Age Sex Outcome Treatment
    1