BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 HEALIX ADVANCE BR3SUT W/OC

    MDR report key: 8271450 · Received January 23, 2019

    Report

    Report Number
    1221934-2018-53288
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Report Date
    January 13, 2017
    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

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4). THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION OF THE ANCHOR UNDER MAGNIFICATION REVEALED THE ANCHOR WAS COMPLETELY BROKEN AT THE DISTAL END, CONFIRMING THIS COMPLAINT. THE BROKEN FRAGMENT WAS HELD IN PLACE BY THE SUTURE. ADDITIONALLY, A CRACK WAS OBSERVED EXTENDING DOWN THE LENGTH OF THE ANCHOR ALONG THE PATH OF THE SCREW THREAD. THE PATTERN OF THE SCREW BREAK ALONG THE THREAD LINE INDICATES POTENTIAL USE OF EXCESS TORSION DURING INSERTION. ANCHOR BREAKAGES ARE TYPICALLY ASSOCIATED WITH OFF AXIS INSERTION, LEVERING DURING INSERTION, HARD BONE QUALITY, OR USING INCORRECT INSTRUMENTATION FOR PREPARING THE BONE HOLE; HOWEVER, THE ROOT CAUSE OF THIS SPECIFIC DEVICE FAILURE CANNOT BE CONCLUSIVELY DETERMINED. REVIEW OF THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY TYPE FOR THIS LOT OF DEVICES RELEASED TO DISTRIBUTION. 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. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 222296, LOT 3912124 COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. 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

    WHEN THE REPORTED ANCHOR WAS INSERTED, IT BROKE. IT HAS CRACKS ON THE ENTIRE CIRCUMFERENCE. THE SURGEON USED A REPLACEMENT AND COMPLETED THE SURGERY WITHOUT A DELAY. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 1-18-2017. NO ADDITIONAL INFORMATION IS AVAILABLE IF AN ADDITIONAL BONE HOLE WAS MADE TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE IF THE INSERTION WAS OFF AXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63656 4.5 HEALIX ADVANCE BR3SUT W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 3912124 10886705021321

    Patients

    Seq Age Sex Outcome Treatment
    1