BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOJIN MICRO TYPE MEDICAL ELECTRIC SAW & DRILL

    MDR report key: 23777762 · Received December 11, 2025

    Report

    Report Number
    MW5180320
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Report Date
    December 4, 2025
    Manufacturer
    SHANGHAI BOJIN ELECTRIC INSTRUMENT & DEVICE CO.,LTD.
    Product Code
    GET
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT: IT WAS REPORTED DURING TOTAL KNEE ARTHROPLASTY THAT THE SAW WAS DEFECTIVE AND COULD NOT BE USED NORMALLY, WHICH DELAYED THE SURGERY BY ONE HOUR AND PREVENTED IT FROM PROCEEDING AS PLANNED. NO PATIENT IMPACT REPORTED. THE INSTRUMENT SUPPLIER WAS IMMEDIATELY CONTACTED TO PROVIDE A REPLACEMENT SAW, WHICH WAS THEN SENT TO THE STERILIZATION SUPPLY ROOM FOR DISINFECTION. THE SURGERY RESUMED ONLY AFTER THE INSTRUMENT WAS DISINFECTED, RESULTING IN A ONE-HOUR DELAY. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2717163 BOJIN MICRO TYPE MEDICAL ELECTRIC SAW & DRILL MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED GET SHANGHAI BOJIN ELECTRIC INSTRUMENT & DEVICE CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown