BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JGRKNT 1.4MM SHRT NDLS 10PK

    MDR report key: 9653430 · Received January 31, 2020

    Report

    Report Number
    0001825034-2020-00313
    Event Type
    Malfunction
    Date Received
    January 31, 2020
    Date of Event
    January 7, 2020
    Report Date
    June 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    UDI-DI
    00880304511699
    PMA / PMN Number
    K110145
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. NO SERIOUS INJURY OR HARM TO THE PATIENT REPORTED FOR THIS EVENT OR PRIOR EVENTS WITH SAME OR SIMILAR PRODUCTS. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    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: ITEM# 912069; JGRKNT 1.4MM SHRT NDLS 10PK; LOT# 810490. FOREIGN: EVENT OCCURRED IN (B)(6). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2020-00312. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUTURE WAS PULLING OUT FROM THE NEEDLE DURING ANCHOR IMPLANTATION. THE ANCHORS WERE SUCCESSFULLY IMPLANTED WHEN OTHER NEEDLE WAS USED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114630 JGRKNT 1.4MM SHRT NDLS 10PK PROSTHESIS, SPORTSMED MBI ZIMMER BIOMET, INC. N/A 810490 00880304511699

    Patients

    Seq Age Sex Outcome Treatment
    1