BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOOT ASSEMBLY

    MDR report key: 8814504 · Received July 22, 2019

    Report

    Report Number
    3005985723-2019-00522
    Event Type
    Malfunction
    Date Received
    July 22, 2019
    Date of Event
    July 9, 2019
    Report Date
    September 25, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486031879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: IT WAS REPORTED THAT CARBON FIBER SPLINTERS CAME OFF FROM THE EDGE OF THE BOOT. THE STAFF PERSON FELT IT ON THEIR FINGER. THEY WOULD LIKE A REPLACEMENT. CASE TYPE: NO ASSOCIATED PROCEDURE. PRODUCT EVALUATION AND RESULTS: PRODUCT INSPECTION SHOWS CHIPPING ON THE CARBON FIBER. PRODUCT HISTORY REVIEW: 1. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 2 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 07-25-2017 WITH NO REPORTED DISCREPANCIES. 2. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 49 DEVICES WERE MANUFACTURED AND 49 REJECTED ON 04-06-2017. ALL THESE 49 DEVICES WERE ACCEPTED VIA QT 17-04-0022 ON 04-04-2017. REVIEW OF QT 17-04-0022 REVEALED THAT THE NON CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. 3. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 1 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 05-12-2017 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N: 210080, LOT: 201743012401 SHOWS 1 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. (B)(4). CONCLUSIONS: PER D03391, PREVENTIVE MAINTENANCE IS WHERE AN ACTION OCCURS THAT IDENTIFIES DEVICE DETERIORATION WHICH MAY COMPROMISE FUNCTION. UNDER PM CONDITIONS NO PATIENT WAS INVOLVED AND NO ACTUAL OR POTENTIAL PATIENT HARM EXISTED FOR THE ALLEGED EVENT. THE FAILURE WAS CONFIRMED VIA VISUAL INSPECTION. 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 THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    CARBON FIBER SPLINTERS CAME OFF FROM THE EDGE OF THE BOOT. THE STAFF PERSON FELT IT ON THEIR FINGER. THEY WOULD LIKE A REPLACEMENT. CASE TYPE: NO ASSOCIATED PROCEDURE.

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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

    CARBON FIBER SPLINTERS CAME OFF FROM THE EDGE OF THE BOOT. THE STAFF PERSON FELT IT ON THEIR FINGER. THEY WOULD LIKE A REPLACEMENT. CASE TYPE: NO ASSOCIATED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606087 BOOT ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 201743012401 00848486031879

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization