BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUPINE BR DS W/ORTHCRD

    MDR report key: 8588098 · Received May 7, 2019

    Report

    Report Number
    1221934-2019-57082
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    April 18, 2019
    Report Date
    April 19, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001101
    PMA / PMN Number
    K150209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS IMPLANTED IN THE PATIENT, THEREFORE, UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART (210712) - LOT NUMBER (L982512) COMBINATION AS PER QLIK QUERY EXECUTED 04/25/2019. 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).

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4). THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS IMPLANTED IN THE PATIENT, THEREFORE, UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART (210712) - LOT NUMBER (L982512) COMBINATION AS PER (B)(4) QUERY EXECUTED 04/25/2019. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA (B)(4) THAT DURING A LABRUM REPAIR, THE SUTURES OF THE LUPINE ANCHOR HAD UNLOADED FROM THE LOOP OF THE LUPINE. THIS OCCURRED AFTER THE SURGEON DRILLED THE PILOT HOLE, MALLETED THE ANCHOR INTO THE BONE, AND REMOVED THE DRILL GUIDE FROM THE BODY. THE ANCHOR WAS LEFT IN THE BONE AND THE PROCEDURE WAS COMPLETED BY CREATING A NEW BONE HOLE AND INSERTING ANOTHER ANCHOR INTO THE PATIENT. THERE WAS A TWO MINUTE DELAY TO CREATE THE NEW BONE HOLE. IT WAS REPORTED THAT THE SUTURES WERE ATTACHED TO THE DRILL GUIDE AND WERE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT A NEW ANCHOR WAS OPENED AND IMPLANTED SUCCESSFULLY. IT WAS REPORTED THAT THERE WERE NO PROCEDURAL OR PATIENT ANATOMY FACTORS WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE. IT WAS REPORTED THAT NO SURGICAL INTERVENTION WAS PLANNED. IT WAS REPORTED THAT THE PATIENT'S BONE QUALITY WAS AVERAGE. IT WAS REPORTED THAT THE INSERTION WAS NOT OFF-AXIS. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED IF THERE WAS PROLONGED HOSPITALIZATION. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. 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
    380427 LUPINE BR DS W/ORTHCRD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L982512 10886705001101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention