BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.75MM HEALIX ADVANCE KNOTLESS BR ANCHOR

    MDR report key: 6881783 · Received September 21, 2017

    Report

    Report Number
    1221934-2017-10515
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    August 23, 2017
    Report Date
    August 23, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K130917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE MULTIPLE REQUESTS SENT OUT FOR DEVICE RETURN, THE COMPLAINT DEVICE WAS NOT RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. A DHR 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 FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED AND A THOROUGH INVESTIGATION WILL BE PERFORMED. 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. UDI: (B)(4).

    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. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED VIA EMAIL DURING A ROTATOR CUFF REPAIR, AT FIRST THE SURGEON USED 22229 4.5 HEALIX BR ANCHOR AND FOUND THAT PATIENT¿S BONE QUALITY WAS SOLID. THEREFORE, THE SURGEON USED 222314 4.5 HEALIX ADVANCE AWL AND 222316 4.5 HEALIX ADVANCE CORTICAL AWL/TAP CONSECUTIVELY DURING THE INSERTION OF 4.75 ANCHOR. AFTER THAT, THE SURGERY WAS PERFORMED ACCORDING TO THE SURGICAL INSTRUCTION. WHEN HALF THE LENGTH OF THE 4.75 ANCHOR WAS BEING INSERTED INTO THE BURR HOLE, 4.75 ANCHOR BROKE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT .THE SURGERY WAS COMPLETED WITHOUT A DELAY. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO HARM TO THE PATIENT. THE BACKUP DEVICE WAS USED TO COMPLETE THE CASE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 8-28-2017. DID THE BREAKAGE RESULT IN SURGICAL DELAY OF GREATER THAN 30 MINUTES OR AN INABILITY TO COMPLETE THE PROCEDURE AS INTENDED? - THE BREAKAGE DID NOT LEAD TO DELAY. IF BREAKAGE OCCURRED NEAR SURGICAL SITE, HOW WERE FRAGMENTS RETRIEVED? - NO ADDITIONAL INFORMATION IS AVAILABLE. WERE ALL THE BROKEN PIECES REMOVED? - YES. HOW WAS THE PROCEDURE COMPLETED? - NO ADDITIONAL INFORMATION IS AVAILABLE. WERE ALTERNATIVES READILY AVAILABLE? - NO ADDITIONAL INFORMATION IS AVAILABLE. WERE THERE ANY PROCEDURAL OR PATIENT ANATOMY FACTORS WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE? - THE SURGEON POINTED OUT ¿ANCHOR-INSERTION ANGLE,¿ ¿SUTURE TENSION,¿ AND ¿SOLID BONE QUALITY.¿ DID THE SURGEON USE THE ORIGINAL BONE HOLE TO COMPLETE THE PROCEDURE? - NO ADDITIONAL INFORMATION IS AVAILABLE. ANY PATIENT IMPACT? - NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661598 4.75MM HEALIX ADVANCE KNOTLESS BR ANCHOR MITEK ANCHOR IMPLANTS MAI DEPUY MITEK L458519

    Patients

    Seq Age Sex Outcome Treatment
    1