BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIPCONTROL

    MDR report key: 18820595 · Received March 1, 2024

    Report

    Report Number
    9611102-2024-00009
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Report Date
    March 1, 2024
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    FSCA700022361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER A THOROUGH INVESTIGATION, RICHARD WOLF GMBH DETERMINED THAT THE ENTIRE BATCH LOT 1548421 OF THE ARTICULATING BURR Ø 4MM (899751754) WAS NOT PROGRAMMED CORRECTLY DUE TO A MANUFACTURING ERROR. THIS RESULTED THAT THE ARTICULATING BURR Ø 4MM NOT BEING RECOGNIZED BY THE HANDLE. NORMALLY, THE PRODUCTS HAVE AN INTERNAL COUNTING MECHANISM THAT COUNTS DOWN WITH EACH ACTIVATION, WHICH LIMITS THE TOTAL FREQUENCY OF USE. THE USER CANNOT IDENTIFY THE FAULTY PRODUCTS WITHOUT A FUNCTIONAL TEST. IT CAN THEREFORE BE ASSUMED THAT CUSTOMERS DO NOT TEST THE PRODUCTS BEFORE USING THEM IN SURGERY, AS THIS WOULD REDUCE THEIR TOTAL USAGE QUANTITY. THE POTENTIAL RISK WAS REASSESSED AND CATEGORIZED AS UNACCEPTABLE AS THERE IS A 100% PROBABILITY OF OCCURRENCE FOR ALL PRODUCTS IN THE BATCH. NO AFFECTED PRODUCTS WERE DELIVERED TO THE USA. IN ABUNDANCE OF CAUTION, RWGMBH HAS TAKEN A PRE-EMPTIVE APPROACH TO IMPLEMENT A SAFETY MEASURE ACCORDINGLY.

    Description of Event or Problem · 0

    A USER HAS INFORMED RICHARD WOLF GMBH (RWGMBH) OF AN ISSUE REGARDING AN ARTICULATING BURR Ø 4MM, PART ID: 899751754, BATCH# 1548421. ACCORDING TO THE RECEIVED INFORMATION, PRIOR TO USE THE ARTICULATING BURR Ø 4MM (899751754) FROM LOT 1548421 WERE NOT PROGRAMMED CORRECTLY. AS A RESULT, THE ARTICULATING BURR IS NOT RECOGNIZED BY THE HANDLE, WHICH POSES A SERIOUS RISK FOR SURGICAL PROCEDURES. IF THIS OCCURS, A DELAY IN THE OPERATION OR EVEN CANCELLATION OF THE OPERATION CAN BE EXPECTED. THERE WAS NO DANGER TO THE PATIENT, USER OR THIRD PARTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921015 TIPCONTROL ARTICULATING BURR Ø 4MM HWE RICHARD WOLF GMBH 899751754 1548421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown