BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX ADVANCE KNTLSS BR

    MDR report key: 8271706 · Received January 23, 2019

    Report

    Report Number
    1221934-2018-53449
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    February 23, 2017
    Report Date
    February 23, 2017
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705023479
    PMA / PMN Number
    K130917
    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. 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. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 222331-LOT #L175048 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 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. 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

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ROTATOR CUFF REPAIR SURGICAL PROCEDURE, THE SURGEON TRIED TO INSERT THE REPORTED 222330 4.75 HEALIX ANCHOR INTO THE BONE HOLE. IT WAS REPORTED THAT WHILE THE SURGEON WAS INSERTING FOUR POLYAMIDE SUTURES (NAMED ¿SURGILON¿) INTO THE ANCHOR, IT CRACKED AND BROKE. IT WAS REPORTED THAT THE SURGEON REPLACED THE DEVICE WITH THE REPORTED 222331 5.5 HEALIX ANCHOR. IT WAS REPORTED THAT THE SURGEON TRIED TO THREAD FOUR FIBERWIRE SUTURES INTO THE ANCHOR. IT WAS REPORTED THAT THE SUTURES DID NOT GO THROUGH THE ANCHOR. IT WAS REPORTED THAT THE SURGEON BROKE THE ANCHOR, SECURED THE SUTURES, AND TOOK OUT THE ANCHOR. THIS TIME HE DID NOT RE-THREAD ALL THE SUTURES ALL AT ONCE. IT WAS REPORTED THAT IT TOOK A FEW TIMES TO RE-THREAD ALL THE SUTURES. IT WAS REPORTED THAT THE SURGEON COMPLETED THE SUTURE BRIDGING. IT WAS REPORTED THAT THE DEVICES WERE BRAND NEW AND THEIR FIRST USE WHEN THE ISSUE OCCURRED. THE SURGERY WAS COMPLETED WITH A 10-MINUTE DELAY. THERE WAS NO HARM TO THE PATIENT. THERE IS NO INFORMATION IF THE ORIGINAL BONE HOLE WAS USED TO COMPLETE THE PROCEDURE OR IF ANY ADDITIONAL DAMAGE WAS MADE TO THE PATIENT DUE TO THIS FAILURE. IT WAS UNKNOWN WHAT SIZE SUTURE WAS USED. 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
    64208 5.5 HEALIX ADVANCE KNTLSS BR SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L175048 10886705023479

    Patients

    Seq Age Sex Outcome Treatment
    1