BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 6909827 · Received October 3, 2017

    Report

    Report Number
    1045254-2017-00343
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 6, 2017
    Report Date
    March 8, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    UDI-DI
    00613994933713
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WE REPORTED 5 DRILLS AND 4 ATTACHMENTS ON MDR 1045254-2017-00343. THIS SUPPLEMENTAL IS TO PROVIDE INFORMATION FOR 1 DRILL, AND THE 4 ATTACHMENTS. INFORMATION ON THE OTHER DRILLS WILL BE PROVIDED IN SUBSEQUENT MDRS, ONE FOR EACH DRILL. ONSITE TESTING WAS PERFORMED, THEY PASSED, THEREFORE THE DEVICES WERE NOT RETURNED TO MEDTRONIC FOR ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THERE WAS A TOTAL OF 5 HANDPIECES WHERE ISSUES WERE REPORTED, NOT EIGHT. THE ORIGINAL MDR FILE INDICATED THERE WERE "THREE HANDPIECES OF PRODUCT # 1845000 - HANDPIECE INDIGO DRILL, SERIAL AND LOT NUMBER UNKNOWN." THIS INFORMATION WAS INCORRECT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1845010 - ATTACHMENT INDIGO STRAIGHT, SERIAL (B)(4), LOT # 206368577), MANUFACTURED DATE: 11/16/2012, 510(K) # K081475, (B)(4). 1845000 - HANDPIECE INDIGO DRILL, SERIAL (B)(4), LOT # 210150121), MANUFACTURED DATE: 09/17/2015, 510(K) # K081475, (B)(4) 1845010 - ATTACHMENT INDIGO STRAIGHT, SERIAL (B)(4), LOT # 212744882, MANUFACTURED DATE: 02/08/2017, 510(K) # K081475, (B)(4) 1845000 - HANDPIECE INDIGO DRILL, SERIAL (B)(4), LOT # 212270285, MANUFACTURED DATE: 11/08/2016, 510(K) # K081475, (B)(4) 1845010 - ATTACHMENT INDIGO STRAIGHT, SERIAL (B)(4), LOT # 211527841, MANUFACTURED DATE: 06/28/2016, 510(K) # K081475, (B)(4) 1845000 - HANDPIECE INDIGO DRILL, SERIAL (B)(4), LOT # 206596771, MANUFACTURED DATE: 01/23/2013, 510(K) # K081475, (B)(4) 1845010 - ATTACHMENT INDIGO STRAIGHT, SERIAL (B)(4), LOT # 209080223, MANUFACTURED DATE: 12/18/2014, 510(K) # K081475, (B)(4) 1845000 - HANDPIECE INDIGO DRILL, SERIAL (B)(4), LOT # 206315872 MANUFACTURED DATE: 11/02/2012, 510(K) # K081475, (B)(4). THREE HANDPIECES OF PRODUCT # 1845000 - HANDPIECE INDIGO DRILL, SERIAL AND LOT NUMBER UNKNOWN. NO ANALYSIS RESULTS AVAILABLE. DEVICE WERE NOT RETURNED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE FIELD TERRITORY MANAGER REPORTED THAT DURING DEVICE SERVICING, HE WENT THROUGH CHECKING 8 MOTORS WITH FOUR STRAIGHT ATTACHMENTS. ONCE THE HANDPIECES REACHED 50K SPEED THEY UNLOCKED AND CAUSED THE MOTOR TO HEAT UP. HE TRIED EACH ATTACHMENT ON EACH MOTOR AND ENDED UP WITH THE SAME RESULT. THERE IS NO PATIENT INVOLVED IN THIS EVENT, NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690347 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 207259154 00613994933713

    Patients

    Seq Age Sex Outcome Treatment
    1