BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8221829 · Received January 7, 2019

    Report

    Report Number
    3005985723-2019-00027
    Event Type
    Malfunction
    Date Received
    January 7, 2019
    Date of Event
    January 2, 2019
    Report Date
    August 3, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT A NUT/BOLT FELL OUT OF THE OPENING OF THE MICS HAND-PIECE FROM INSIDE THE BARREL. PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION WAS NOT PERFORMED AS THIS WAS A FUNCTIONAL FAILURE. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS PERFORMED, AND THE DEVICE FAILED THE TEST. PER CASE NUMBER 168357, THE ALLEGED FAILURE MODE WAS CONFIRMED. UNABLE TO REPAIR MICS AS WITH THE NEW CABLE DID NOT FIX THE ISSUE. DISPOSITION - (RETURN TO VENDOR). RTV REASON: CROSS THREADED NUT. PRODUCT HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORD INDICATE THAT (B)(4) DEVICES WERE MANUFACTURED UNDER LOT NO K082X AND WERE INSPECTED ALONG WITH 01 DEVICES OF DIFFERENT LOT AND 19 DEVICES OF THE REPORTED LOT AND 01 DEVICE OF DIFFERENT LOT WERE ACCEPTED INTO FINAL STOCK ON 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 RELATED TO PARTS IN LOT NUMBER K082X, P/N 209063 SHOWS NO OTHER COMPLAINT 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 THAT THERE HAVE BEEN NO NC¿S ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    A NUT/BOLT FELL OUT OF THE OPENING OF THE MICS HAND-PIECE FROM INSIDE THE BARREL. 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

    A NUT/BOLT FELL OUT OF THE OPENING OF THE MICS HAND-PIECE FROM INSIDE THE BARREL. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14975 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. LOT NUMBER: 42040716SERIAL N 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization