BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUPINE BR DS W/ORTHCRD

    MDR report key: 8535763 · Received April 22, 2019

    Report

    Report Number
    1221934-2019-56902
    Event Type
    Injury
    Date Received
    April 22, 2019
    Date of Event
    March 28, 2019
    Report Date
    March 29, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001101
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: HTY; JDR; MBI; GAM; GAS; GAT. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART-LOT NUMBER COMBINATION. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER REPAIR PROCEDURE THE FIRST LUPINE ANCHOR WITH ORTHOCORD PULLED OUT OF THE BONE UPON DRILLING AND INSERTION. THE SECOND PREPARED SITE WAS DRILLED AND THE ANCHOR WAS MALLETED DOWN THE GUIDE, BUT WHEN REMOVING THE INSERTER, THE SECOND LUPINE ANCHOR WITH ORTHOCORD SUTURE UNLOADED FROM THE ANCHOR AND LEFT NOTHING EXCEPT THE ANCHOR AND THE LOOP IN THE BONE. THE CASE WAS COMPLETED SUCCESSFULLY, BUT THE PROCEDURE WAS DELAYED SEVEN TO EIGHT MINUTES DURING WHICH TIME THE NEW ANCHOR WAS OPENED. IT WAS NOTED FRAGMENTS WERE CREATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. BOTH ANCHORS WERE REMOVED FROM THE PATIENT WITH A GRASPER; NO DEBRIS WAS LEFT IN THE PATIENT. NEW LUPINE ANCHORS WERE OPENED AND USED SUCCESSFULLY. IT WAS NOTED FOUR (4) BONE HOLES WERE CREATED DURING THE CASE. IT WAS NOTED THE PATIENT¿S BONE QUALITY WAS AVERAGE. THE SURGEON WAS PULLING ON THE ANCHORS WITHOUT OVERLY EXERTING. THE ANCHOR DID NOT REMAIN ON THE INSERTER AFTER REMOVAL FROM THE CANNULA. THE SUTURE DID NOT WRAP AROUND THE HANDLE OR DRIVER. THE SURGEON WAS NOT GRASPING THE SUTURE DURING REMOVAL. THE SURGEON USED APPROPRIATE DOWNWARD FORCE APPLIED WITH DRIVING ANCHOR IN. IT WAS NOTED THE SURGEON USED PROPER SUTURE MANAGEMENT. THIS REPORT IS FOR A LUPINE ANCHOR WITH ORTHOCORD. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328335 LUPINE BR DS W/ORTHCRD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 210712 2L16210 10886705001101

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR