BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT MINI SOFT ANCHORS

    MDR report key: 7577347 · Received June 7, 2018

    Report

    Report Number
    0001825034-2018-03790
    Event Type
    Injury
    Date Received
    June 7, 2018
    Date of Event
    May 9, 2018
    Report Date
    June 14, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    PK110879
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 912076 JGRKNT 1.0MM MINI 2-0 NDLS 886150; 110005315 JGRKNT SHORT RIGID SZ2 IMP/DRL 792220; 110005315 JGRKNT SHORT RIGID SZ2 IMP/DRL 877030; 110005315 JGRKNT SHORT RIGID SZ2 IMP/DRL 257170. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS SCRAPPED. 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: 0001825034-2018-03791.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO RELATED DEVIATIONS OR ANOMALIES THAT LEAD TO THE REPORTED EVENT. ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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 PERONEAL TENDON REPAIR PROCEDURE, TWO ANCHORS PULLED OUT AFTER BEING SEATED. AN ADDITIONAL HOLE WAS DRILLED TO COMPLETE THE SURGERY WITH NEW ANCHORS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420511 JUGGERKNOT MINI SOFT ANCHORS FASTENER, FIXATION MBI ZIMMER BIOMET, INC. N/A 138760

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R