BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX BR ANCHOR W/OCORD

    MDR report key: 8266675 · Received January 22, 2019

    Report

    Report Number
    1221934-2018-52800
    Event Type
    Malfunction
    Date Received
    January 22, 2019
    Date of Event
    July 27, 2016
    Report Date
    November 18, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705007790
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 REVEALED THAT THE ANCHOR WAS COMPLETELY BROKEN MEDIALLY, CONFIRMING THIS COMPLAINT. THE BROKEN DISTAL FRAGMENT WAS NOT RETURNED. 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. ADDITIONALLY, VISUAL INSPECTION REVEALED THAT THE HANDLE OF THE INSERTER WAS EXTREMELY DEFORMED AND SHOWED EVIDENCE OF MELTING AND/OR CRUSHING; HOWEVER, A ROOT CAUSE FOR THE OBSERVED DAMAGE CANNOT BE 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. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 222233-LOT #3896849 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. 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. 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 A SHOULDER LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 5.5 HEALIX BR ANCHOR W/OCORD ANCHOR DEVICE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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
    59413 5.5 HEALIX BR ANCHOR W/OCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 3896849 10886705007790

    Patients

    Seq Age Sex Outcome Treatment
    1