BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 HEALIX BR ANCHOR W/OCORD

    MDR report key: 8071055 · Received November 14, 2018

    Report

    Report Number
    1221934-2018-55295
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    September 1, 2018
    Report Date
    September 17, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705007769
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATIONS REVEALS NO ANOMALIES. THE DEVICE APPEARS TO BE INTACT AND UNUSED. ADDITIONALLY, THE SUTURE SHOWS NO SIGNS OF DAMAGE. THEREFORE, THIS COMPLAINT CANNOT BE CONFIRMED. FURTHERMORE, A NONCONFORMANCE SEARCH WAS PERFORMED AND NO NONCONFORMANCES WERE IDENTIFIED WITH THIS PART: 222229 WITH LOT: L758181 COMBINATION. AT THIS 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 TO MONITOR THE EXTENT TO WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE ANCHOR SUTURE "SHREDDED" AWAY FROM THE ANCHOR DURING TENSIONING. ACCORDING TO THE REPORTER, THE TWO ANCHORS FAILED AS THE SUTURES FRAYED AND BROKE WHERE IT CONNECTS TO THE ANCHOR. IT WAS REPORTED THAT BOTH ANCHORS WERE REMOVED AND NEW ANCHORS WERE INSERTED IN EXISTING BONE HOLES TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE EVENT HAPPENED ON TWO CONSECUTIVE ANCHORS. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH SUTURES FROM A DIFFERENT LOT #. 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. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2018: IT WAS REPORTED THE ANCHOR DID NOT BREAK DURING INSERTION INTO THE BONE; THE SUTURE SHREDDED AT BASE OF ANCHOR. NO AWL WAS USED. THERE WAS NO AUDIBLE OR TACTILE INDICATION OF FAILURE. ONE ORTHOCORD SUTURE WITH TWO TAILS WAS USED. THE ANCHOR WAS FULLY REMOVED AND WAS OUTSIDE THE JOINT SPACE. THE ANCHOR DID NOT BREAK WHILE PULLING THE SUTURE THROUGH THE SYSTEM. IT WAS NOTED THE SUTURE LIMBS WERE EQUAL IN LENGTH AND NOT TANGLED. THE ANCHOR DID NOT BREAK WHILE LOOKING FOR THE HOLE. THE AREA WAS ADEQUATELY CLEARED. NO SPECIAL SURGICAL TECHNIQUE WAS USED. THE SURGEON DID NOT LEVER ON THE ANCHOR WHILE SEARCHING FOR THE HOLE. IT WAS NOTED VERY MINIMAL FORCES WERE APPLIED TO THE SYSTEM WHILE SEARCHING FOR THE HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912035 4.5 HEALIX BR ANCHOR W/OCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L758181 10886705007769

    Patients

    Seq Age Sex Outcome Treatment
    1