BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JGRKNT SINGLE 1.4MM 1 #1 MB

    MDR report key: 7320560 · Received March 7, 2018

    Report

    Report Number
    0001825034-2018-01691
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    February 1, 2018
    Report Date
    May 31, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    PK110145
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 912030, JGRKNT SINGLE 1.4MM 1 #1 MB, P04389, 912030, JGRKNT SINGLE 1.4MM 1 #1 MB, 200570, 912030, JGRKNT SINGLE 1.4MM 1 #1 MB, P06314, 912140C, JGRKNT 1.4MM CRVD KIT W SLV, 028790. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (B)(6). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01690, 0001825034 - 2018 - 01689, 0001825034 - 2018 - 01692.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. FOUR JUGGERKNOTS ARE RETURNED FOR EVALUATION. ALL FOUR ANCHORS ARE OFF THE PUSHER AND APPEARED TO BE OWN OR USED. THREE OF THE PUSHERS ARE APPEARED TO BE BENT. FUNCTIONAL TESTING IS NOT POSSIBLE AS THE DEVICES WERE RETURNED DISASSEMBLED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF REPAIR THE ANCHORS WERE UNABLE TO BE RETAINED IN THE PATIENT'S BURR HOLE. SOME OF THE ANCHORS PULLED OUT FROM THE PATIENT'S BURR HOLE, AND THE OTHER PRODUCTS WOULD NOT INSERT INTO THE HOLE. DEFORMATIONS WERE SEEN ON THE INSERTERS. AS A RESULT, ADDITIONAL HOLES HAD TO BE DRILLED IN PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164166 JGRKNT SINGLE 1.4MM 1 #1 MB FASTENER, FIXATION MBI ZIMMER BIOMET, INC. N/A P04389

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R