BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3D GRAFTRASP SYSTEM

    MDR report key: 12250337 · Received July 29, 2021

    Report

    Report Number
    3012495575-2021-00001
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    July 23, 2021
    Report Date
    July 29, 2021
    Manufacturer
    SURGENTEC, LLC
    Product Code
    FMF
    PMA / PMN Number
    K201900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN USED EXCESSIVE FORCE TO MALLET THE CURVED PUSHER. BECAUSE THERE WAS GRAFT BOUND UP IN THE CURVED RASP IT CAUSED THE FIRST PUSHER TO BEND AT THE HEAD AND BREAK, AND THEN BECOME PINNED AGAINST THE NITINOL WIRE. THEY COULD NOT FIND THE HEAD BECAUSE IT WAS STILL STUCK INSIDE THE CURVED RASP. WE FOUND THE PIECE WHEN WE CUT OPEN THE RASP AFTER ATTEMPTING TO CLEAR IT, SINCE WE COULD NOT CLEAR THE CURVED RASP, WE CUT IT OPEN. WHEN THEY ATTEMPTED THE MALLET THE SECOND CURVED PUSHER IT BROKE BECAUSE THERE WAS STILL GRAFT IN ADDITION TO THE MUSHROOM HEAD OF THE PREVIOUS CURVED PUSHER, NOW STUCK INSIDE THE CURVED RASP HANDLE. THE USE OF MALLETING CAUSED AN IMPACT FORCE WHICH IS CAUTIONED AGAINST IN THE SURGICAL TECHNIQUE AND CAUSED THE BREAK OF THE NITINOL. IN ADDITION, THE WRONG BONE GRAFT WAS USED WITH THE INSTRUMENT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PUSHING GRAFT ( A BONEGRAFT THAT WAS TO GRANUALAR, NOT HYDRATED / FLOWABLE) THROUGH THE CURVED RASP HANDLE WHEN IT BECAME STUCK. THE DOCTOR INSERTED THE CURVED PUSHER TO ATTEMPT TO RELEASE THE GRAFT BUT IT WAS INEFFECTIVE. THE PHYSICIAN THEN MALLETED ON TOP OF THE CURVED PUSHER TO TRY AND DISLODGE STUCK GRAFT. THE SALES REPRESENTATIVE DESCRIBED IT AS THE PHYSICIAN MALLETED ON THE CURVED PUSHER WITH EXCESSIVE FORCE. ONCE HE PULLED THE CURVED PUSHER OUT HE NOTICED THE MUSHROOM TIP WAS MISSING. THEY LOOKED FOR MUSHROOM TIP, X-RAYED THE PATIENT AND COULDN'T FIND IT (AFTER THE INSTRUMENT WAS RETURNED TO THE MANUFACTURER, THE MUSHROOM TIP WAS LOCATED BURIED WITHIN THE INSTRUMENT'S TUBE). SINCE IT WAS NOT INSIDE THE PATIENT THEY ASSUMED IT FELL ON THE FLOOR AND MOVED TO ANOTHER CURVED PUSHER TO ATTEMPT TO DISLODGE THE GRAFT. THE PHYSICIAN TOOK A SECOND CURVED PUSHER AND TRIED PUSHING THE STUCK GRAFT THROUGH AGAIN. THIS TIME THE NITINOL WIRE BROKE. THE SALES REPRESENTATIVE DESCRIBED IT AS THE PHYSICIAN MALLETED THE CURVED PUSHER ONCE AGAIN WITH EXCESSIVE FORCE. THEY FOUND THE BROKEN PIECE AND FINISHED THE SURGERY BY USING A STRAIGHT RASP HANDLE TO PUSH THROUGH NEW GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147470 3D GRAFTRASP SYSTEM PISTON SYRINGE AND BONE RASP FMF SURGENTEC, LLC 20201127003

    Patients

    Seq Age Sex Outcome Treatment
    1