BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8440075 · Received March 21, 2019

    Report

    Report Number
    3005985723-2019-00254
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    March 5, 2019
    Report Date
    June 18, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS. BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: IT WAS REPORTED THAT LOCKING MECHANISM FELL OFF MICS DUE TO PIN VIBRATING OUT. IS STUCK IN LOCKED POSITION, HANDLE CANNOT BE SWUNG PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION VISUAL INSPECTION CONFIRMED THAT THE PIVOT PIN IS BROKEN. ATTEMPTS TO REPAIR THE DEVICE WERE UNSUCCESSFUL AND THE PART WAS RTV FOR REWORK. FUNCTIONAL, DIMENSIONAL AND MATERIAL ANALYSIS INSPECTION WERE NOT PERFORMED AS VISUAL INSPECTION CONFIRMED THE FAILURE. AS PER WO-01599182 AND CASE NUMBER 03446855. FAILURE MODE WAS DUPLICATED AND PRODUCT WAS RETURNED TO VENDOR. PRODUCT HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORD INDICATE THAT 25 DEVICES WERE MANUFACTURED UNDER LOT NO K082X AND 01 DEVICE UNDER LOT NO K08C2. 19 DEVICES WERE ACCEPTED UNDER LOT NO K082X AND 01 DEVICE WAS ACCEPTED UNDER LOT NO K08C2 INTO FINAL STOCK 12/13/2016. REVIEW OF QT-16-12-0040 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, PRODEX LOT K082X SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE MODE WAS DUPLICATED FOR THE ALLEGED FAILURE. ATTEMPTS TO REPAIR WERE UNSUCCESSFUL AND THE PART WAS RTV FOR REWORK. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT NC 1414517 AND CAPA 1450904 ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    LOCKING MECHANISM FELL OFF MICS DUE TO PIN VIBRATING OUT. IS STUCK IN LOCKED POSITION, HANDLE CANNOT BE SWUNG. CASE TYPE: TKA. 1. WHEN WAS ISSUE NOTICED? (PRIOR, DURING, OR AFTER CASE)? AS PER THE MPS- WAS NOTICED DURING THE CASE. 2. DID THE LOCKING MECHANISM FALL OFF OVER THE OPERATING FIELD WHERE THE OPEN WOUND WAS LOCATED? AS PER THE MPS - FELL OFF THE ROBOT ONTO THE DRAPE IN THE SURGICAL FIELD. WAS NOT IN/NEAR THE WOUND HOWEVER.

    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

    LOCKING MECHANISM FELL OFF MICS DUE TO PIN VIBRATING OUT. IS STUCK IN LOCKED POSITION, HANDLE CANNOT BE SWUNG. CASE TYPE: TKA. WHEN WAS ISSUE NOTICED? (PRIOR, DURING, OR AFTER CASE)? AS PER THE MPS- WAS NOTICED DURING THE CASE. DID THE LOCKING MECHANISM FALL OFF OVER THE OPERATING FIELD WHERE THE OPEN WOUND WAS LOCATED? AS PER THE MPS - FELL OFF THE ROBOT ONTO THE DRAPE IN THE SURGICAL FIELD. WAS NOT IN/NEAR THE WOUND HOWEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232987 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4200950 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization