BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5 HEALIX ADVANCE BR ANCHOR WITH ORTHOCORD

    MDR report key: 5409026 · Received February 3, 2016

    Report

    Report Number
    1221934-2016-10010
    Event Type
    Injury
    Date Received
    February 3, 2016
    Date of Event
    December 15, 2015
    Report Date
    December 15, 2015
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    PK120078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION AND THEREFORE A ROOT CAUSE FOR THIS FAILURE CANNOT BE DISCERNED. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT ANY INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED AND A THOROUGH INVESTIGATION WILL BE PERFORMED. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ASSOCIATED MEDWATCH FOR SECOND DEVICE: 1221934-2016-10009. (B)(4). THE LOT EXPIRATION DATE IS CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    AUTOCAPTURE DIVING BOARD (214158) DID NOT WORK, COULD NOT RETAIN THE SUTURES WITHIN THE DIVING BOARD. HEALIX ADVANCE 5.5MM (222297) AFTER PASSING THE LIMBS OF THE SUTURES THROUGH THE TISSUE, WHILST SLIDING THE KNOT, BOTH THE SUTURES BROKE. UPON CHECKING THE SUTURES DID NOT BREAK DISTALLY, IT BROKE ALMOST NEAR THE MIDDLE. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT WITH A DELAY OF 30 MINUTES. BOTH DEVICES WERE USED ON THE CUFF. FIRST ANCHOR WAS NOT REMOVED, ADDITIONAL HOLE WAS CREATED FOR SECOND BONE ANCHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66833 5.5 HEALIX ADVANCE BR ANCHOR WITH ORTHOCORD ANCHOR IMPLANTS MAI DEPUY MITEK 3860742

    Patients

    Seq Age Sex Outcome Treatment
    1 Other