BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX ADVANCE BR W/OC&ND

    MDR report key: 8272154 · Received January 23, 2019

    Report

    Report Number
    1221934-2018-53409
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    February 22, 2017
    Report Date
    February 22, 2017
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705021352
    PMA / PMN Number
    K120078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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. ONLY ONE SEGMENT OF VIOLET SUTURE WAS RETURNED. ONE END OF THE SUTURE WAS FRAYED, INDICATIVE OF A BREAK, CONFIRMING THIS COMPLAINT. THE RETURNED SEGMENT OF SUTURE WAS TESTED FOR STRAIGHT TENSILE STRENGTH AND KNOT TENSILE STRENGTH USING AN MTS MACHINE. STRAIGHT TENSILE RESULTS MET THE INTERNAL DESIGN VERIFICATION SPECIFICATION OF AVERAGE 42LBS (TEST RESULT = 52LBS) AND KNOT TENSILE RESULTS MET THE USP REQUIREMENT SPECIFICATION OF AVERAGE MINIMUM 24LBS (TEST RESULT = 32LBS). HISTORICALLY, THIS FAILURE HAS BEEN OBSERVED WHEN THE SUTURE OR PART OF THE SUTURE COMES IN CONTACT WITH A SHARP OBJECT; HOWEVER, A ROOT CAUSE FOR THIS SPECIFIC DEVICE FAILURE CANNOT BE CONCLUSIVELY DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD FOR THE FINISHED GOODS ASSEMBLY (P/N 222299) INDICATED THAT THIS BATCH OF (B)(4) DEVICES WAS PROCESSED WITHOUT INCIDENT. REVIEW OF THE DEVICE HISTORY RECORD FOR THE VIOLET #2 ORTHOCORD SUTURE (COMPONENT P/N 108149) INDICATED THAT THIS BATCH OF (B)(4) STRANDS WAS PROCESSED WITHOUT INCIDENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT ONE OF THE ORTHOCORD WIRES OF THE 5.5 HEALIX ADVANCE BR W/OC&ND ANCHOR DEVICE BUSTLED WHEN THE SURGEON WAS SUTURING THE CUFF. ACCORDING TO THE REPORTER, THE PURPLE SUTURE BROKE. THERE WAS A FIVE MINUTE DELAY IN THE SURGERY TO COMPLETE THE PROCEDURE BUT THE SURGEON WASN'T ABLE TO TIE THE SECOND KNOT. IT WAS REPORTED THAT PART OF THE PURPLE SUTURE WOULD BE RETURNED AS THE REST OF THE ANCHOR GOT IMPLANTED. 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
    65152 5.5 HEALIX ADVANCE BR W/OC&ND SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 3853342 10886705021352

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization