BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JGRKNT 1.0MM MINI 3-0 NDLS

    MDR report key: 10004522 · Received April 28, 2020

    Report

    Report Number
    0001825034-2020-01656
    Event Type
    Malfunction
    Date Received
    April 28, 2020
    Date of Event
    March 25, 2020
    Report Date
    August 26, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K140908
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G4, G7, H1, H2, H3, H6, H10 . D4 MULTIPLE LOTS WERE USED DURING THE SURGERY: LOT# 053280 UDI# (B)(4). STERILE EXPIRATION DATE: OCT 31, 2024 MANUFACTURING DATE: OCT 21, 2019 LOT# 536840 UDI# (B)(4).STERILE EXPIRATION DATE: OCT 31, 2024 MANUFACTURING DATE: OCT 21, 2019 REPORTED EVENT WAS CONFIRMED BY REVIEW OF PICTURES. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THAT THE PRONG HAS FRACTURED AND THE SUTURE DISASSEMBLED FROM THE INSERTER. DEVICE HISTORY RECORD 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE LOTS WERE USED DURING THE SURGERY: LOT# 053280, UDI# UNK, STERILE EXPIRATION DATE: UNK, MANUFACTURING DATE: UNK. LOT# 536840, UDI# UNK, STERILE EXPIRATION DATE: UNK, MANUFACTURING DATE: UNK. REPORT SOURCE: FOREIGN: EVENT OCCURRED IN (B)(6). THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF THE INSERTER WAS FRACTURED WHILE THE SURGEON TRIED TO INSERT THE ANCHOR IN THE BURR HOLE. THE FRACTURED PIECE WAS REMOVED FROM THE PATIENT'S BODY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471407 JGRKNT 1.0MM MINI 3-0 NDLS PROSTHESIS, SPORTSMED MBI ZIMMER BIOMET, INC. N/A REFERENCE H10

    Patients

    Seq Age Sex Outcome Treatment
    1