BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7615672 · Received June 19, 2018

    Report

    Report Number
    3005985723-2018-00380
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Date of Event
    June 18, 2018
    Report Date
    September 14, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: IT WAS REPORTED THAT THE HANDLE LOCKING MECHANISM FAILED DURING THE CASE. PRODUCT EVALUATION AND RESULTS: "VISUAL INSPECTION: VISUAL INSPECTION REVEALED THAT THE HANDLE PIVOT LATCH DISLOCATED FROM THE HANDPIECE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED AS VISUAL AND FUNCTIONAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. MATERIAL ANALYSIS: MATERIAL ANALYSIS WAS NOT COMPLETED AS VISUAL AND FUNCTIONAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION REVEALED THAT THE HANDPIECE HANDLE COULD NOT BECOME UNLOCKED BECAUSE THE LATCH TO UNLOCK THAT FUNCTION HAD DISLOCATED." PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K08Z6 AND ALL (B)(4) INCLUDING 4201543 WERE REJECTED ON 02/11/2017. A REVIEW OF QT17-02-0042 REVEALED THAT THE ISSUE WAS RELATED TO THE WRONG C OF C DOCUMENT REVISION. THE DEVICE WAS RE-INSPECTED WITH THE CORRECT C OF C DOCUMENTATION AND RELEASED INTO THE FIELD. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 209063, PRODEX LOT K08Z6 SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    THE PART THAT ENGAGES THE HANDLE FELL OFF. THE PIN THAT HOLDS IT IN PLACE VIBRATED OFF. THE PIN AND THE LEVER WAS FOUND. PKA/TKA/THA: TKA.

    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

    THE PART THAT ENGAGES THE HANDLE FELL OFF. THE PIN THAT HOLDS IT IN PLACE VIBRATED OFF. THE PIN AND THE LEVER WAS FOUND. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455974 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 420412164201543 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization