BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7717861 · Received July 25, 2018

    Report

    Report Number
    3005985723-2018-00442
    Event Type
    Malfunction
    Date Received
    July 25, 2018
    Date of Event
    July 24, 2018
    Report Date
    November 2, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE MANUFACTURER NAME, CITY AND STATE, MFR SITE, DATE REC¿D BY MFR, PMA/510K, IF FOLLOW-UP WHAT TYPE AND DEVICE EVALUATED BY MFR BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: IT WAS REPORTED THAT AFTER MAKING ONE CUT THE MICS WOULD NO LONGER MOVE SAWBLADE, HOWEVER THE MICS WAS JUST SPINNING FREELY RESULTING IN SURGICAL DELAY OF 30 - 60 MINS. PRODUCT EVALUATION AND RESULTS: NO DEVICE INSPECTION COULD BE COMPLETED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT: K08EN AND ALL 25 INCLUDING 4201164 WERE REJECTED FROM FINAL STOCK ON 3/6/2017. A REVIEW OF QT17-03-0012 REVEALED THAT THE ISSUE WAS THAT THE C OF C WAS THE INCORRECT REVISION. THE CLERICAL ERROR WAS CORRECTED AND THE PARTS WERE ACCEPTED INTO FINAL STOCK. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N: (B)(4), PRODEX LOT: K08EN SHOWS NO ADDITIONAL COMPLAINT(S) 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 THAT NC: 1414517 AND CAPA: 1450904 ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    AFTER MAKING ONE CUT, MICS WOULD NO LONGER MOVE SAWBLADE. THE MICS WAS JUST SPINNING FREELY; TKA UPDATE: DELAY WAS 30 - 60 MINS.

    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

    AFTER MAKING ONE CUT, MICS WOULD NO LONGER MOVE SAWBLADE. THE MICS WAS JUST SPINNING FREELY; TKA. UPDATE: DELAY WAS 30 - 60 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562375 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42030916/4201172 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization