BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JGRKNT 1.0MM MINI 3-0 NDLS

    MDR report key: 10407435 · Received August 14, 2020

    Report

    Report Number
    0001825034-2020-03174
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 17, 2020
    Report Date
    November 19, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    DZL
    PMA / PMN Number
    K140908
    Removal / Correction Number
    NI
    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. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED 5 JUGGERKNOT MINIS WERE RETURNED BECAUSE THE CLEAR SLEEVE WOULDN¿T MOVE SMOOTHLY. 3 RETURNED WITH SUTURES AND ANCHORS AND 2 DID NOT. 4 OF 5 HAVE THE SLEEVE FULLY DEPLOYED AGAINST THE HANDLE UPON RECEIPT. ITEM AND LOT NUMBERS ARE NOT CONFIRMED AS THEY ARE NOT ETCHED ON THE PART. ALL 5 DEVICES WERE FUNCTION CHECKED ACCORDING TO THE FUNCTIONAL TESTING OF THE JUGGERKNOT MINI SLEEVE MEMO. ALL 5 FUNCTION AS INTENDED AND ARE CONFORMING. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE A COMPATIBILITY REVIEW IS NOT APPLICABLE. MEDICAL RECORDS WERE NOT PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. NO DEVICE PROBLEM FOUND; THE RETURNED PRODUCTS WERE CONFORMING DURING FUNCTIONAL CHECK. 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 MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-03172, 0001825034-2020-03173, 0001825034-2020-03175, 0001825034-2020-03176. CONCOMITANT MEDICAL DEVICES: PART# 912082; LOT# 003010, PART# 912082; LOT# 071710, PART# 912082; LOT# 554580, PART# 912082; LOT# 725310. FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT 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. 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 APPROXIMATELY FOUR (4) WEEKS AGO DURING SURGERY, THE CLEAR SLEEVE OF THE JUGGERKNOT MINI WOULD NOT MOVE. THE SURGEON TRIED USING FIVE (5) DIFFERENT JUGGERKNOT MINIS OF THE SAME MODEL, ALL WHICH HAD THIS PROBLEM. THERE WAS A SURGICAL DELAY FOR AN UNKNOWN AMOUNT OF TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874420 JGRKNT 1.0MM MINI 3-0 NDLS SCREW, FIXATION, INTRAOSSEOUS DZL ZIMMER BIOMET, INC. NI 504430

    Patients

    Seq Age Sex Outcome Treatment
    1