BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8125923 · Received December 3, 2018

    Report

    Report Number
    3005985723-2018-00700
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 7, 2018
    Report Date
    February 26, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT AFTER SURGERY WAS COMPLETED I WAS TAKING OUT THE SAW ATTACHMENT AND A SMALL BOLT FELL OUT OF THE MICS HANDPIECE. THERE WAS 1 BOLT MISSING OUT OF THE 3 BOLTS FROM THE INSIDE OF THE HANDPIECE. PRODUCT EVALUATION AND RESULTS: AS PER ATTACHED PICTURE IT SHOWS THAT ONE SCREW WAS MISSED FROM THE DEVICE BUT FURTHER INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K087T AND 23 INCLUDING 4201023 WERE ACCEPTED INTO FINAL STOCK ON 9/7/16. 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 P/N 209063, PRODEX LOT K087T SHOWS 0 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT THERE HAVE BEEN NO NC AND CAPA ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    AFTER SURGERY WAS COMPLETED I WAS TAKING OUT THE SAW ATTACHMENT AND A SMALL BOLT FELL OUT OF THE MICS HANDPIECE. THERE WAS 1 BOLT MISSING OUT OF THE 3 BOLTS FROM THE INSIDE OF THE HANDPIECE. CASE TYPE: 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

    AFTER SURGERY WAS COMPLETED I WAS TAKING OUT THE SAW ATTACHMENT AND A SMALL BOLT FELL OUT OF THE MICS HANDPIECE. THERE WAS 1 BOLT MISSING OUT OF THE 3 BOLTS FROM THE INSIDE OF THE HANDPIECE CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964449 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42020816/4201008 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization