BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 6898489 · Received September 27, 2017

    Report

    Report Number
    3005985723-2017-00470
    Event Type
    Malfunction
    Date Received
    September 27, 2017
    Date of Event
    September 26, 2017
    Report Date
    December 6, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS AND BASED ON THE RESULTS OF INVESTIGATION. "REPORTED EVENT: IT WAS REPORTED THAT HANDPIECE DID NOT WORK. ISSUE WAS NOTICED DURING CASE, THEREFOR THERE WAS NO CASE DELAY AND NO PATIENT HARM. DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K093E AND (B)(4) INCLUDING 4201666 WERE ACCEPTED INTO FINAL STOCK ON 03/15/2017. A REVIEW OF (B)(4) REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO PARTS IN LOT NUMBER K093E, P/N 209063 SHOWS 1 OTHER COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINT INVESTIGATIONS ARE: (B)(4) . VISUAL INSPECTION: VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE OF UNIT. THE SCREW WAS OUTSIDE OF THE UNIT. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION: THE HANDPIECE MOTOR AND ELECTRONICS FUNCTION AS INTENDED. CONCLUSIONS: THE SCREW HOLDS THE HANDLE IN PLACE. IF THE SCREW BACKS OUT THEN THE HANDLE CAN FALL. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT (B)(4) AND CAPA (B)(4) ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT."

    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

    MICS HAND PIECE MALFUNCTION .DURING POSTERIOR CHAMFER CUT FOR TKA PROCEDURE, GREY HAND PIECE CAME UNSCREWED FROM THE MICS HANDLE AND FELL ON TO THE FIELD.

    Description of Event or Problem · 1

    MICS HAND PIECE MALFUNCTION .DURING POSTERIOR CHAMFER CUT FOR TKA PROCEDURE, GREY HAND PIECE CAME UNSCREWED FROM THE MICS HANDLE AND FELL ON TO THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677627 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization