BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8707076 · Received June 18, 2019

    Report

    Report Number
    3005985723-2019-00435
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    June 5, 2019
    Report Date
    August 30, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: IT WAS REPORTED THAT IN BETWEEN CUTS THE HANDLE OF THE MICS HANDPIECE FELL OFF OF THE MICS. THE SCREW AS FOUND AND SCREWED BACK INTO THE HANDLE. WHILE SCREWING THE HANDLE BACK ON THE SCRUB TECH TOLD US IT FELT STRIPED. PRODUCT EVALUATION AND RESULTS: NO DEVICE INSPECTION COULD BE COMPLETED AS THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. PRODUCT HISTORY REVIEW: "REVIEW OF DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K049Z. ALL (B)(4) DEVICES INCLUDING S/N (B)(6) WERE REJECTED ON 06/26/2015. A REVIEW OF QT 15-04-0015 REVEALED THAT THE ISSUES WERE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. (B)(6) WAS LATER ACCEPTED INTO FINAL STOCK ON 07/06/15. A REVIEW OF QT 15-06-0054 REVEALED THAT THE ISSUES WERE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT." COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO PARTS IN LOT NUMBER K049Z, P/N 209063 SHOWS NO OTHER COMPLAINT 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 THERE HAVE BEEN AN NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THIS IS NC (B)(4) AND CAPA 1452931 H3 OTHER TEXT : PRODUCT WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    IN BETWEEN CUTS THE HANDLE OF THE MICS HANDPIECE FELL OFF OF THE MICS. THE SCREW AS FOUND AND SCREWED BACK INTO THE HANDLE. WHILE SCREWING THE HANDLE BACK ON THE SCRUB TECH TOLD US IT FELT STRIPED. CASE TYPE: TKA. SURGICAL DELAY: ABOUT 30 SECONDS.

    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

    IN BETWEEN CUTS THE HANDLE OF THE MICS HANDPIECE FELL OFF OF THE MICS. THE SCREW AS FOUND AND SCREWED BACK INTO THE HANDLE. WHILE SCREWING THE HANDLE BACK ON THE SCRUB TECH TOLD US IT FELT STRIPED. CASE TYPE: TKA. SURGICAL DELAY: ABOUT 30 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501943 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42010315 / 4200076 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization