BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUPORT

    MDR report key: 6190326 · Received December 20, 2016

    Report

    Report Number
    3008812173-2016-00038
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    November 16, 2016
    Report Date
    August 2, 2019
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    FGY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH A NON-ROUTINE REVIEW OF THE COMPLAINT FILE, IT WAS RECOGNIZED THAT THE INCORRECT PART NUMBER WAS SUBMITTED ON THE INITIAL MEDWATCH, REPORT NUMBER 3008812173-2016-00038, ON DECEMBER 20, 2016. THIS MEDWATCH IS BEING SUBMITTED TO CORRECT THE PRODUCT INFORMATION.

    Description of Event or Problem · 0

    SIDE-DELIVERY ACCUPORT BROKE AT PROXIMAL HOLE WHEN SURGEON TRIED TO REPOSSITION.

    Additional Manufacturer Narrative · 1

    (B)(6) WERE CONTACTED ON DEC 20TH TO INVESTIGATE THIS COMPLAINT. ON (B)(6) OF 2016, DR. (B)(6) PERFORMED SCP ON A PATIENT¿S POSTERIOR LATERAL FEMUR. AFTER INJECTING ~3CC OF BSM, THE SURGEON BACKED UP THE ACCUPORT® CANNULA IN AN ATTEMPT TO RE-DIRECT IT MORE DISTALLY. IT WAS NOTED THAT THE STYLUS DID NOT FULLY ENGAGE THE CANNULA BEFORE BACKING IT UP AND WHILE TRYING TO RE-DIRECT; IT WAS SAID TO BE CLOSE THOUGH. IN THE PROCESS OF BENDING THE ACCUPORT® CANNULA TO THE NEW TRAJECTORY, THE INSTRUMENT BROKE AT THE MOST PROXIMAL FENESTRATION. THE SURGEON ATTEMPTED TO RETRIEVE THE BROKEN PIECE, BUT THAT RESULTED IN THE PIECE GETTING PUSHED A BIT DEEPER INTO THE PATIENT. THE SURGEON DECIDED TO LEAVE THE BROKEN PIECE IN. DR. (B)(6) OPENED A SECOND ACCUPORT® CANNULA AND INJECTED THE REMAINING BSM INTO HIS DESIRED LOCATION. HE COMMENTED THAT THIS RESULTED IN LITTLE TO NO DELAY IN SURGERY AND THAT A WEEK LATER, THE PATIENT SEEMS WELL AND IS ¿BACK TO PLAYING BASKETBALL.¿ THE BROKEN CANNULA WAS: P/N 307.032 ¿ LOT 32407 WHICH WAS PULLED FROM A KIT P/N 402.202 ¿ LOT KC02442. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    SIDE-DELIVERY ACCUPORT BROKE AT PROXIMAL HOLE WHEN SURGEON TRIED TO REPOSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842316 ACCUPORT CANNULA FGY ZIMMER KNEE CREATIONS, INC. N/A 32407

    Patients

    Seq Age Sex Outcome Treatment
    1