BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7053460 · Received November 22, 2017

    Report

    Report Number
    3005985723-2017-00578
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    November 14, 2017
    Report Date
    February 6, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE BASED ON THE RESULTS OF INVESTIGATION. "REPORTED EVENT: IT WAS REPORTED THAT THE HANDPIECE SCREW WAS LOOSE. ISSUE WAS NOTICED WHILE REAMING THE ACETABULUM. CASE, THEREFOR THERE WAS YES CASE DELAY AND NO PATIENT HARM. DEVICE HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K07V8 AND (B)(4) INCLUDING 4200846 WERE ACCEPTED INTO FINAL STOCK ON 7/21/16. 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 K07V8, P/N 209063 SHOWS 2 OTHER COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINT INVESTIGATIONS ARE: (B)(4). MATERIAL INSPECTION: MATERIAL ANALYSIS WAS NOT COMPLETED BECAUSE FUNCTIONAL INSPECTION CLEARLY SHOWED FAILURE. 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) ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT."

    Description of Event or Problem · 0

    THE GREY PART OF THE MICS HANDLE BROKE OFF WHILE REAMING DURING THA CASE. THERE WAS A VERY SHORT DELAY TO INVESTIGATE WHAT HAPPENED TO THE HANDLE. UPDATED INFORMATION: 1-2 MINUTE DELAY IN THE CASE. SURGERY COMPLETED SUCCESSFULLY WITH THE ROBOT.

    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 GREY PART OF THE MICS HANDLE BROKE OFF WHILE REAMING DURING THA CASE. THERE WAS A VERY SHORT DELAY TO INVESTIGATE WHAT HAPPENED TO THE HANDLE. ***UPDATED INFORMATION***: 1-2 MINUTE DELAY IN THE CASE. SURGERY COMPLETED SUCCESSFULLY WITH THE ROBOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831899 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization