BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOKNOTLESS RC #2 ETHGR *EA

    MDR report key: 8540443 · Received April 23, 2019

    Report

    Report Number
    1221934-2019-56913
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 2, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705002238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: HTY; JDR; MBI. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE, UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER (212738), LOT NUMBER (L320098) 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

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN ARCR SURGERY THE BIOKNOTLESS ETHIBOND ANCHOR CAME OFF FROM THE BONE HOLE WHEN THE SURGEON IMPLANTED INTO THE PATIENT'S SHOULDER. THUS, THE SURGEON COULD NOT IMPLANT AND FIX THE ANCHOR. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM, ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. THERE WERE NO BROKEN PARTS IN THE PATIENT¿S BODY. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO INFORMATION OF SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. THIS REPORT IS FOR A BIOKNOTLESS ETHIBOND ANCHOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334304 BIOKNOTLESS RC #2 ETHGR *EA SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 212738 L320098 10886705002238

    Patients

    Seq Age Sex Outcome Treatment
    1