BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX ADVANCE BR W/OCORD

    MDR report key: 7695273 · Received July 17, 2018

    Report

    Report Number
    1221934-2018-51451
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    September 25, 2013
    Report Date
    September 25, 2013
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705021338
    PMA / PMN Number
    K120078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 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. (B)(4). 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

    IT WAS REPORTED BY THE SALES REP THAT THE SURGEON WAS PERFORMING ARTHROSCOPIC ROTATOR CUFF REPAIR ON (B)(6) MALE WITH NO COMORBIDITIES. SURGEON SUCCESSFULLY IMPLANTED 1 EACH 222297 (HEALIX ADVANCE 5.5MM BR ANCHOR) USING THE 5.5/6.5MM HEALIX ADVANCE AWL PER THE IFU. SURGEON USED SAME AWL AND WAS INSERTING THE SECOND (OF THREE TOTAL) HEALIX ADVANCE 5.5MM BR ANCHORS. AFTER APPROXIMATELY 2 FULL TURNS OF THE ANCHOR IN THE TUNNEL, THE ANCHOR FRACTURED LONGITUDINALLY (FROM DISTAL TO PROXIMAL). SURGEON IMMEDIATELY REMOVED THE INSERTER FROM THE JOINT; SUTURES CAME OUT WITH THE INSERTER. HE THEN TOOK A TISSUE GRASPER AND ¿FISHED¿ OUT THE TWO ANCHOR HALVES WITH NO ISSUE. SURGICAL TECHNICIAN DISCARDED THE BROKEN ANCHOR. SURGEON THEN TOOK THE 5.5/6.5MM AWL/TAP AND REINSERTED INTO THE SAME HOLE TO ENSURE THERE WAS ENOUGH ROOM TO ACCOMMODATE ANOTHER ANCHOR. HE TOOK THIS STEP BECAUSE HE ASSUMED THE PATIENT HAD HARDER BONE THAN ANTICIPATED AS EVIDENCED BY THE FIRST ANCHOR IMPLANTED WITH NO PROBLEM WHEN HE USED JUST THE AWL. HE TOOK ANOTHER HEALIX ADVANCE 5.5MM BR ANCHOR AND IMPLANTED IT INTO THE SAME HOLE WITH NO ISSUE. HE TESTED THE ANCHOR¿S INTEGRITY BY PULLING ON THE SUTURES, AND IT HELD FIRMLY IN THE BONE. SURGEON COMPLETED THE PROCEDURE BY USING THE 5.5/6.5MM AWL/TAP INSTRUMENT FOR THE THIRD AND FINAL ANCHOR, WHICH WAS ANOTHER HEALIX ADVANCE 5.5MM BR ANCHOR. THIS LAST ANCHOR HELD AS DESIGNED. SURGEON ENSURED THERE WERE NO REMNANTS OF THE BROKEN ANCHOR REMAINING IN THE JOINT SPACE. AT NO TIME WAS THE PATIENT¿S HEALTH AT RISK DURING THIS PROCEDURE. DEVICE WAS DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537343 5.5 HEALIX ADVANCE BR W/OCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 3653469 10886705021338

    Patients

    Seq Age Sex Outcome Treatment
    1