BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DS

    MDR report key: 8744413 · Received June 28, 2019

    Report

    Report Number
    1221934-2019-57460
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    June 5, 2019
    Report Date
    June 6, 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 · 1

    PATIENT ID REPORTED AS (B)(6). ADDITIONAL PROCODES: HTY, JDR, MBI. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART-LOT NUMBER COMBINATION. 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 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. (B)(4). 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 BICEP TENODESIS, THE LUPINE ANCHOR WITH ORTHOCORD WAS BEING INSERTED WHEN IT CRUMBLED, AND THE SUTURES WERE RELEASED. FRAGMENTS WERE GENERATED, AND PART OF THE ANCHOR REMAINED IN THE PATIENT. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY AS A NEW ANCHOR WAS OPENED AND RE-DRILLED. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A LUPINE BR DS WITH ORTHCORD. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537996 LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DS FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI DEPUY MITEK LLC US 210712 2L44218 10886705001101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention