BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX ADVANCE KNTLSS BR

    MDR report key: 8270309 · Received January 23, 2019

    Report

    Report Number
    1221934-2018-53093
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    December 15, 2016
    Report Date
    December 15, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705023479
    PMA / PMN Number
    K130917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION REVEALED THAT THE ANCHOR WAS BROKEN INTO TWO FRAGMENTS, CONFIRMING THIS COMPLAINT. THE ANCHOR BROKE AT THE DISTAL END WHERE THE FIRST THREAD BEGINS. VISUAL INSPECTION REVEALED THAT THE DISTAL TIP WAS DISTORTED INTO AN ELLIPSE, INDICATING POTENTIAL USE OF EXCESS TORSION DURING INSERTION WHICH WOULD HAVE COMPRESSED THE TIP OF THE ANCHOR INTO THE OBSERVED ELLIPSE AND CAUSED THE ANCHOR TO BREAK. OTHER TYPICAL CAUSES OF ANCHOR BREAKAGES WHICH MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE OFF AXIS INSERTION, LEVERING DURING INSERTION, HARD BONE QUALITY, OR USING INCORRECT INSTRUMENTATION FOR PREPARING THE BONE HOLE. 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 222331-LOT #3927419 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 ETQ 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 CUSTOMERS HEALIX ADVANCE KNOTLESS BR 5.5 MM ANCHOR BROKE UPON INSERTION DURING AN UNSPECIFIED SURGICAL PROCEDURE. THE SURGEON WAS ABLE TO COMPLETE THE CASE BY PUTTING ANOTHER ANCHOR IN THE SAME BONE HOLE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS. 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
    63769 5.5 HEALIX ADVANCE KNTLSS BR SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 3927419 10886705023479

    Patients

    Seq Age Sex Outcome Treatment
    1