BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7746911 · Received August 3, 2018

    Report

    Report Number
    3005985723-2018-00452
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Date of Event
    July 25, 2018
    Report Date
    December 26, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT ALL INITIAL BONE CUTS WERE MADE AND AT THE TIME THE DR. ASSESSED THE JOINT HE FELT THAT THE KNEE WAS TIGHT IN EXTENSION. SO WE DECIDED TO RECUT DISTAL FEMUR AT THIS TIME SAW WOULD NOT WORK. COULD HEAR MOTOR SO TRIED TO RESET CUTTER. THAT DIDN¿T WORK. ASKED DR. TO REMOVE SAW ATTACHMENT AND THAT IS WHEN A GEAR FROM MISC. FELL OUT OF THE HAND PIECE. SO WE GOT MICS FROM SHELF. REASSEMBLED TO RIO AND REGISTERED. PRODUCT EVALUATION AND RESULTS: PRODUCT INSPECTION COULD NOT BE PERFORMED AS THE PRODUCT WAS LOST AND NOT AVAILABLE FOR EVALUATION. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K070G AND 23 INCLUDING 4200510 WERE ACCEPTED INTO FINAL STOCK ON 3/9/16. A REVIEW OF QT-16-03-0026 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO PARTS IN LOT NUMBER K070G, P/N 209063 SHOWS 01 OTHER COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINT PR: (B)(4). CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN AN NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THIS IS NC1414517 AND CAPA 1450904. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    ALL INITIAL BONE CUTS WERE MADE AND AT THE TIME THE DR. ASSESSED THE JOINT HE FELT THAT THE KNEE WAS TIGHT IN EXTENSION. SO WE DECIDED TO RECUT DISTAL FEMUR AT THIS TIME SAW WOULD NOT WORK. COULD HEAR MOTOR SO TRIED TO RESET CUTTER. THAT DIDN¿T WORK. ASKED DR. TO REMOVE SAW ATTACHMENT AND THAT IS WHEN A GEAR FROM MISC. FELL OUT OF THE HAND PIECE. SO WE GOT MICS FROM SHELF. REASSEMBLED TO RIO AND REGISTERED. AND DID OUR RECUTS. CASE TYPE: TKA. WAS THERE A SURGICAL DELAY? YES =15 MINUTES.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ALL INITIAL BONE CUTS WERE MADE AND AT THE TIME THE DR. ASSESSED THE JOINT HE FELT THAT THE KNEE WAS TIGHT IN EXTENSION. SO WE DECIDED TO RECUT DISTAL FEMUR AT THIS TIME SAW WOULD NOT WORK. COULD HEAR MOTOR SO TRIED TO RESET CUTTER. THAT DIDN¿T WORK. ASKED DR. TO REMOVE SAW ATTACHMENT AND THAT IS WHEN A GEAR FROM MISC. FELL OUT OF THE HAND PIECE. SO WE GOT MICS FROM SHELF. REASSEMBLED TO RIO AND REGISTERED. AND DID OUR RECUTS. CASE TYPE: TKA. WAS THERE A SURGICAL DELAY? YES =15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589140 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. LOT 42020216 SN# 4200510 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization