BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 13231827 · Received January 11, 2022

    Report

    Report Number
    1045254-2022-00016
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    June 3, 2021
    Report Date
    January 11, 2022
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    UDI-DI
    00643169882621
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS FOUND THAT THE HANDPIECE WAS RECEIVED IN GOOD CONDITION. NO ANOMALIES HAVE BEEN FOUND. NOTE: BOTH HANDPIECES WERE USED ON THE SAME SURGERY, BUT THE CUSTOMER IS NOT ABLE TO DISTINGUISH WHICH ONE OVERHEATED. HENCE, WE'RE SUBMITTING MDRS ON BOTH HANDPIECES. THE HANDPIECES ARE THE FOLLOWING: PRODUCT:1845000, S/N:(B)(4) AND PRODUCT:1845000, S/N:(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A HEALTH CARE PROVIDER REPORTED THAT THEY HAD AN ISSUE WITH DRILL NO.1 WAS SCREAMING LOUDLY. IT WAS CLOCKED AT OVER 90 DECIBELS. THEY OPENED THE SECOND ONE, WHICH WHEN DRILLING IN PRETTY HARD BONE WITH A 2MM BUR THE HAND PIECE STARTED TO GET HOT. WHEN THEY USED A 4MM BURR IT SEEMED TO SETTLE. THE DRILL NO.1 (SCREAMER) HAD THE STRAIGHT HAND PIECE ON DURING THE CASE. THERE WAS NO PATIENT IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT THE HOSPITAL IS NOT ABLE TO IDENTIFY AT THIS LATE STAGE WHICH WAS THE FAULTY ONE AS THEY BOTH HAD AN OUTSTANDING MAINTENANCE ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803707 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MEDTRONIC XOMED INC. 1845000 216574407 00643169882621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown