BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX ADVANCE BR W/OCORD

    MDR report key: 8273250 · Received January 24, 2019

    Report

    Report Number
    1221934-2018-53463
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Date of Event
    February 22, 2017
    Report Date
    February 28, 2017
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705021338
    PMA / PMN Number
    K120078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS 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. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 222297, LOT 3914669 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 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 AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT ONE OF THE THREAD (DARK ATIGRADA) RUPTURED WHEN MAKING THE FIRST KNOT WHEN PLACING THE 5.5 HEALIX ADVANCE BR W/OCORD DEVICE. ACCORDING TO THE REPORTER, THIS THREAD WAS OUTSIDE THE THREAD TAB (THE SALES REP. DID NOT THINK THAT IT MAY BE THE CAUSE) AND THE SURGEON WAS BLOCKING THE KNOT AND THEIR THREAD RUPTURED. THE SURGEON COMPLETED THE PROCEDURE BY USING THE ORIGINAL ANCHOR DEVICE BUT WITH ANOTHER THREAD THAT WAS AVAILABLE FOR USE. THE SURGEON DID NOT USE ANY ADDITIONAL SUTURE, IT WAS NOT NECESSARY TO OPEN AN ADDITIONAL ANCHOR, BECAUSE IT WAS LEFT THE OTHER THREAD WITH WHICH IT WAS SUFFICIENT TO FINISH THE REPAIR OF THE CUFF. IT WAS NOT NECESSARY TO MAKE AN ADDITIONAL BONE HOLE. THERE WAS NO EXCESSIVE FORCE THAT WOULD CAUSE THE SUTURE TO RUPTURE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS THE ORIGINAL 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
    66450 5.5 HEALIX ADVANCE BR W/OCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 3914669 10886705021338

    Patients

    Seq Age Sex Outcome Treatment
    1