BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERSTITCH CURVED IMPLANT

    MDR report key: 9291448 · Received November 7, 2019

    Report

    Report Number
    0001825034-2019-05003
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    October 28, 2019
    Report Date
    February 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    UDI-DI
    00880304690073
    PMA / PMN Number
    K150424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED NO SERIOUS INJURY WAS REPORTED AS A RESULT OF THIS MALFUNCTION. ADDITIONALLY, THIS MALFUNCTION HAS NOT PREVIOUSLY BEEN REPORTED FOR HAVING CAUSED A SERIOUS INJURY ON A SAME/SIMILAR DEVICE IN THE PAST. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED NO SERIOUS INJURY WAS REPORTED AS A RESULT OF THIS MALFUNCTION. ADDITIONALLY, THIS MALFUNCTION HAS NOT PREVIOUSLY BEEN REPORTED FOR HAVING CAUSED A SERIOUS INJURY ON A SAME/SIMILAR DEVICE IN THE PAST. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110024773, JUGGERSTITCH CURVED IMPLANT, 020620. 110024773, JUGGERSTITCH CURVED IMPLANT, 020620. 110024773, JUGGERSTITCH CURVED IMPLANT, 020620. 110024773, JUGGERSTITCH CURVED IMPLANT, 020620. 110024773, JUGGERSTITCH CURVED IMPLANT, 002180. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05004, 001825034-2019-05005, 0001825034-2019-05006. IT IS UNAWARE WHICH FOUR JUGGERSTITCH FAILED OUT OF THE SIX REPORTED, HENCE ALL THE FOUR POSSIBLE COMBINATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INITIAL SURGERY AFTER DEPLOYING MULTIPLE JUGGERSTITCH DEVICES, WHEN PULLING FINAL TENSION ON THE SUTURES, ONE OF THE JUGGERKNOTS PULLED OUT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084470 JUGGERSTITCH CURVED IMPLANT FASTENER, FIXATION MBI ZIMMER BIOMET, INC. 110024773 020620 00880304690073

    Patients

    Seq Age Sex Outcome Treatment
    1