BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7134665 · Received December 20, 2017

    Report

    Report Number
    3005985723-2017-00633
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    December 14, 2017
    Report Date
    April 11, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: IT WAS REPORTED THAT THE SCREW HOLDING THE HANDLE OF THE MICS FELL OF, RESULTING IN THE SURGICAL DELAY OF 5 MIN IN A TKA CASE. PRODUCT EVALUATION AND RESULTS: NO DEVICE INSPECTION COULD BE COMPLETED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. (B)(4) HAS BEEN INITIATED IN REGARDS TO MISSING PRODUCT. PRODUCT HISTORY REVIEW: REVIEW OF PRODUCT HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K08UF AND 24 INCLUDING 4201386 WERE ACCEPTED INTO FINAL STOCK ON 01/24/2017. A REVIEW OF QT17-01-0086 REVEALED THAT THE NON- CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, LOT NUMBER K08UF SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. 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 (B)(4) AND CAPA (B)(4).

    Description of Event or Problem · 0

    DURING SECOND (RIGHT) SIDE OF A BILATERAL KNEE OPERATION, IN THE MIDDLE OF CUTS WITH STRAIGHT SAW ATTACHMENT, THE BOLT HOLDING THE WHITE GRIP OF THE MICS TO THE MICS POWER SYSTEM FELL OUT OF THE POWER AND ONTO THE SURGICAL FIELD. THE BOLT WAS QUICKLY LOCATED BY AN ASSISTANT AND THE SURGEON WAS ADVISED TO USE COBAN/IOBAN TO KEEP THE WHITE HANDLE ATTACHED TO POWER. THIS WAS DONE TO MAINTAIN PROPER GRIP ON THE POWER/SAW ATTACHMENT.

    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

    DURING SECOND (RIGHT) SIDE OF A BILATERAL KNEE OPERATION, IN THE MIDDLE OF CUTS WITH STRAIGHT SAW ATTACHMENT, THE BOLT HOLDING THE WHITE GRIP OF THE MICS TO THE MICS POWER SYSTEM FELL OUT OF THE POWER AND ONTO THE SURGICAL FIELD. THE BOLT WAS QUICKLY LOCATED BY AN ASSISTANT AND THE SURGEON WAS ADVISED TO USE COBAN/IOBAN TO KEEP THE WHITE HANDLE ATTACHED TO POWER. THIS WAS DONE TO MAINTAIN PROPER GRIP ON THE POWER/SAW ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914264 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4201386 / 42041116

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization