BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8263514 · Received January 21, 2019

    Report

    Report Number
    3005985723-2019-00066
    Event Type
    Malfunction
    Date Received
    January 21, 2019
    Date of Event
    January 15, 2019
    Report Date
    July 29, 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 TO UPDATE SECTIONS D.3, G.1, G.4, G.7, H.2, H.3, H.6, H.10 AND H.11 BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: IT WAS REPORTED THAT MICS HANDLE SCREW BACKED OUT AND HANDLE FELL OFF MICS AT END OF CUTS. PRODUCT EVALUATION AND RESULTS: AS PER CASE NUMBER (B)(4), THE ALLEGED FAILURE WAS CONFIRMED. 1. UNABLE TO REPAIR MICS AS WITH THE NEW CABLE DID NOT FIX THE ISSUE. DISPOSITION - (RETURN TO VENDOR). RTV REASON: LOOSE SCREWS ON HANDPIECE. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER PRODEX LOT K05BN AND 19 WERE ACCEPTED INTO FINAL STOCK ON 8/22/2015. A REVIEW OF QT15-08-0048 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, LOT NUMBER K05BN SHOWS NO ADDITIONAL COMPLAINTS 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 AN NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THIS IS (B)(4) AND CAPA 1452931.

    Description of Event or Problem · 0

    MICS HANDLE SCREW BACKED OUT AND HANDLE FELL OFF MICS AT END OF CUTS. 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

    MICS HANDLE SCREW BACKED OUT AND HANDLE FELL OFF MICS AT END OF CUTS. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56961 HANDPIECE MICS STEREOTAXTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4200138/42030715 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization