BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY GORILLA/GORILLA PLATING SYSTEM

    MDR report key: 11628898 · Received April 7, 2021

    Report

    Report Number
    3008650117-2021-00080
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 2, 2021
    Report Date
    April 7, 2021
    Manufacturer
    PARAGON 28, INC.
    Product Code
    HWC
    PMA / PMN Number
    K190365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT NUMBER TC29409R WAS REVIEWED AND SHOWS ALL INSPECTED PARTS WERE RECEIVED AND ACCEPTED. NO NCR IDENTIFIED ON DHR. ON 4/19/2021, THE PART WAS RECEIVED. VISUAL OBSERVATION OF THE RETURED PART CONFIRMED THE FAILURE MODE; DRIVER BROKEN AT THE TIP. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR LOT NUMBER TC29409R WAS REVIEWED AND SHOWS ALL INSPECTED PARTS WERE RECEIVED AND ACCEPTED. NO NCR IDENTIFIED ON DHR. AS OF 4/7/2021, THE PART WAS NOT RETURNED TO THE MANUFACTURER. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ON (B)(6) 2021, A PARAGON 28 SCREW DRIVER BROKE WHILE EXPLANTING A SCREW THAT WAS TOO LONG. THE REPORTER STATED THAT THE BREAKAGE DID NOT INTERFERE WITH THE IMPLANT PLACEMENT. IT WAS REPORTED THAT THE SURGERY WAS DELAYED FOR MORE THAN 30 MINUTES, IN THE ATTEMPT TO FIND A SUITABLE DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529125 BABY GORILLA/GORILLA PLATING SYSTEM SCREW DRIVER ATTACHMENT, SOLID, LONG, AO, HX-15 HWC PARAGON 28, INC. P99-191-SB15 TC29409R

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR P99-000-AOMN MINI-AO, RATCHETING HANDLE