BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8816993 · Received July 23, 2019

    Report

    Report Number
    3005985723-2019-00528
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    July 15, 2019
    Report Date
    September 23, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: MICS CLIP AND PIN IN BACK USED TO ROTATE HANDLE FELL OFF DUE TO VIBRATIONS OF THE CUT. CANNOT MANIPULATE HANDLE. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION WAS PERFORMED AND CONFIRMED THAT PIN IN THE MICS FELL OFF. ATTEMPTS TO REPAIR WERE UNSUCCESSFUL. RTV REASON: MICS FAILED PIVOT HANDLE LOCKING TEST. FUNCTIONAL INSPECTION, DIMENSIONAL INSPECTION AND MATERIAL ANALYSIS. ANALYSIS WERE NOT PERFORMED AS VISUAL INSPECTION CONFIRMED THE FAILURE. PER WORK ORDER NUMBER AND CASE NUMBER PART WAS RTV FOR REWORK. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K078L AND 18 INCLUDING 4200599 WERE ACCEPTED INTO FINAL STOCK ON 5/16/16. REVIEW OF QT16 - 05 - 0060 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 K078L, P/N 209063 SHOWS NO OTHER COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT NO NC/CAPA ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    MICS CLIP AND PIN IN BACK USED TO ROTATE HANDLE FELL OFF DUE TO VIBRATIONS OF THE CUT. CANNOT MANIPULATE HANDLE. CASE TYPE: (B)(4).

    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

    MICS CLIP AND PIN IN BACK USED TO ROTATE HANDLE FELL OFF DUE TO VIBRATIONS OF THE CUT. CANNOT MANIPULATE HANDLE. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611901 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42030316 / 4200580 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization