BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER STICK M5/3

    MDR report key: 21567348 · Received March 10, 2025

    Report

    Report Number
    9611102-2025-00010
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    October 9, 2024
    Report Date
    March 10, 2025
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE CURRENT INSPECTION BY THE SPECIALIST DEPARTMENT IN ACCORDANCE WITH PA-01-001-8874, IT WAS FOUND THAT THE CONNECTOR 15210016 IS CORRODED. THE CORRODED CONNECTOR PINS, AS WELL AS THE RESULTING MALFUNCTIONS, ARE DUE TO IMPROPER CLEANING/REPROCESSING. IN THIS REGARD, THE USER IS ADVISED IN GA-A304 / EN / V4.0 / 2020-07 / PK20-0081 IN CHAPTER 8.3.1 THAT THE ELECTRICAL CONTACTS ON THE CONNECTION CABLE MUST BE COMPLETELY DRY AFTER CLEANING. REGARDING THE CURRENT CONDITION OF THE PLUG PINS, WE ASSUME THAT LIQUIDS WERE NOT REMOVED WHEN THE CONNECTION CABLE WAS CONNECTED AND THAT THIS CAUSED CORROSION, AS WELL AS THE CLAIMED FUNCTIONAL STOP. THE MOTOR HANDLE TYPE 899550003 WITH THE SERIAL NUMBER (B)(6) WAS PRODUCED ON 02/17/2023 (BATCH 1530100 WITH A BATCH SIZE OF 5) AND DELIVERED TO THE CUSTOMER ON 03/07/2023. NO DISCREPANCIES OR SPECIAL RELEASES WERE FOUND DURING THE REVIEW OF THE FLOW DIAGRAM. IN THE PERIOD UNDER CONSIDERATION, NO COMPARABLE CASE OF THIS TYPE 89955.0003 HAS BEEN REGISTERED. IN GENERAL, THE USER IS ADVISED IN THE ASSOCIATED GA-A238 INSTRUCTIONS FOR USE UNDER CHAPTER 4 , THAT A VISUAL AND FUNCTIONAL CHECK MUST BE PERFORMED BEFORE AND AFTER EACH USE. POSSIBLE DAMAGE/MALFUNCTIONS OF THE ABOVE TYPE CAN BE EASILY DETECTED BY HOSPITAL STAFF IF THESE INSTRUCTIONS ARE FOLLOWED. IN OUR RISK ANALYSIS E5-2, MANUFACTURING-RELATED, HANDLING-RELATED AND DESIGN-RELATED HAZARDS REGARDING A FUNCTIONAL IMPAIRMENT AS WELL AS RISKS DUE TO AN UNUSABLE PRODUCT WITH THE CORRESPONDING EXTENT OF DAMAGE AND THE ASSUMED PROBABILITY OF OCCURRENCE WERE CONSIDERED AND ASSESSED WITH AN ACCEPTABLE RISK.

    Description of Event or Problem · 0

    ACCORDING TO THE RECEIVED INFORMATION, THE INSTRUMENT DID NOT WORK DURING AN ARTHROSCOPIC KNEE SURGERY. THE SURGERY WAS POSTPONED UNTIL THE HOSPITAL RECEIVED ANOTHER DEVICE, AND THE SURGERY WAS PERFORMED. THERE ARE NO PROBLEMS OR COMPLICATIONS AND THE PATIENT IS DOING PERFECTLY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197745 POWER STICK M5/3 MOTOR HANDPIECE MAX. 16000RPM GEY RICHARD WOLF GMBH 899550003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other