BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5 HEALIX ADVANCE BR3SUT W/OC

    MDR report key: 7454804 · Received April 24, 2018

    Report

    Report Number
    1221934-2018-50516
    Event Type
    Injury
    Date Received
    April 24, 2018
    Date of Event
    March 27, 2018
    Report Date
    March 28, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705021321
    PMA / PMN Number
    K120078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT AND NO NON-CONFORMANCE 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 AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI: (B)(4). THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE. ASSOCIATED MEDWATCHES: 1221934-2018-50517 AND 1221934-2018-50518.

    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. (B)(4). THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE. ASSOCIATED MEDWATCHES: 1221934-2018-50517 AND 1221934-2018-50518.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BACK OUT OF THE ANCHOR (P/N:222296) WAS NOTED AFTER INSERTING TO THE BONE HOLE DURING ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2018. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE ANCHOR (SAME P/N, LOT NUMBER WAS UNKNOWN). THE SURGEON DID NOT FEEL THAT THE BONE QUALITY WAS FRAGILE. IT WAS ALSO, REPORTED THAT THE SURGEON FELT DIFFICULTY TO INSERT THE ANCHOR (P/N: 222330) BECAUSE THE ANCHOR WAS IDLE WHEN THE SURGEON INSERTED THE ANCHOR TO THE PATIENT¿S BONE DURING THE SAME SURGERY OF FIRST EVENT. THEN, THE SURGEON TOOK OUT THE ANCHOR AND FOUND THERE WAS A CRACK ON THE ANCHOR. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE ANCHOR (SAME P/N, LOT NUMBER WAS UNKNOWN). THEN, IT WAS REPORTED THAT THE ANCHOR (P/N: 222330) WAS COME OUT TOGETHER WITH THE INSERTER AFTER FIXING THE ANCHOR TO THE PATIENT¿S BONE DURING THE SAME SURGERY OF FIRST AND SECOND EVENTS. THE SURGERY WAS COMPLETED BY OPENING ANOTHER BONE HOLE TO BE INSERTED SO THAT THE ANCHOR COULD BE FIXED. THE SURGEON COMMENTED THAT THE BONE QUALITY MAY HAVE BEEN THINNER IN THE CORTEX AND FRAGILE IN THE CANCELLOUS BONE. THESE WERE BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296605 4.5 HEALIX ADVANCE BR3SUT W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L621125 10886705021321

    Patients

    Seq Age Sex Outcome Treatment
    1 Other