BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8288340 · Received January 30, 2019

    Report

    Report Number
    3005985723-2019-00076
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    January 14, 2019
    Report Date
    August 6, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT SMALL SCREW ON BACKSIDE OF BLUE MICS HANDPIECE FELL OUT INTO THE FIELD. PRODUCT EVALUATION AND RESULTS: PER CASE NUMBER (B)(4) THE ALLEGED FAILURE WAS NOT CONFIRMED. 1.SUCCESSFULLY PERFORMED MICS CABLE REPLACEMENT PER (B)(4). MICS CAN BE RETURNED TO STOCK AS A 209063 LOT #4200431-R. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K06QD AND WERE ACCEPTED INTO FINAL STOCK ON 3/22/16.NO NON-CONFORMANCE WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 209063, PRODEX LOT K06QD SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS NOT CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT THERE HAVE BEEN NO NC AND CAPA ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    SMALL SCREW ON BACKSIDE OF BLUE MICS HANDPIECE FELL OUT INTO THE FIELD. CASE TYPE: TKA.

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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

    SMALL SCREW ON BACKSIDE OF BLUE MICS HANDPIECE FELL OUT INTO THE FIELD. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81769 HANDPIECE MICS STEREOTAXTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42010116 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization