BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JGRKNT 1.0MM MINI 3-0 NDLS

    MDR report key: 9982428 · Received April 21, 2020

    Report

    Report Number
    0001825034-2020-01625
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    February 7, 2020
    Report Date
    September 22, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    DZL
    UDI-DI
    00880304523418
    PMA / PMN Number
    K140908
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPDATED: B4, B5, G4, H1, H2, H3, H6, H10. VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED ONE HAS THE NEEDLE BENT AND ONE HAS THE SLEEVE MISSING. THE REMAINING THREE DEVICES WERE TESTED USING THE BONE PLATE AND WERE FOUND WITHIN CONFORMANCE. THE RETURNED DEVICES DID NOT HAVE LOT NUMBERS ON THEM, THEREFORE IT IS NOT KNOWN WHICH WERE CONFORMING AND WHICH HAD A MISSING SLEEVE AND WHICH WAS BENT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 912082, JGRKNT 1.0MM MINI 3-0 NDLS, LOT # 931540, CATALOG #: 912082, JGRKNT 1.0MM MINI 3-0 NDLS, LOT # 931540, CATALOG #: 912082, JGRKNT 1.0MM MINI 3-0 NDLS, LOT # 124630, CATALOG #: 912082, JGRKNT 1.0MM MINI 3-0 NDLS, LOT # UNK. 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: 0001825034-2020-01623, 0001825034-2020-01624, 0001822565-2020-01425, 0001825034-2020-01769.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THE PRODUCTS PLASTIC SLEEVE DID NOT GUIDE EASILY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447819 JGRKNT 1.0MM MINI 3-0 NDLS FASTENER, FIXATION DZL ZIMMER BIOMET, INC. N/A 931540 00880304523418

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR