BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOOT ASSEMBLY

    MDR report key: 8964281 · Received September 5, 2019

    Report

    Report Number
    3005985723-2019-00642
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    August 28, 2019
    Report Date
    April 13, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486031879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: SPD TECH REPORTS GETTING A SPLINTER FROM BROKEN CARBON FIBER. CASE TYPE: NO ASSOCIATED PROCEDURE. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION : THE BOOT ASSEMBLY SHOWED A BROKEN EDGE WITH CARBON FIBER SPLINTERS. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS NOT CONDUCTED SINCE DEFECT WAS CONFIRMED IN VISUAL INSPECTION. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT CONDUCTED SINCE DEFECT WAS CONFIRMED IN VISUAL INSPECTION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT 201543030601. (B)(4) DEVICES WERE ACCEPTED INTO FINAL STOCK ON 12/21/2015. (B)(4) DEVICES WERE ACCEPTED INTO FINAL STOCK ON 5/13/2016. (B)(4) DEVICES WERE ACCEPTED INTO FINAL STOCK ON 04/16/2016. AND (B)(4) DEVICES WERE DISPOSITION ACCORDING TO QT15-05-0023 AND QT16-03-0073. NO NON CONFORMANCE WERE RELATED TO THE FAILURE REPORTED IN THE EVENT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 210080 , LOT NUMBER 201543030601 SHOWS 01 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION.PR ID : (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 ALLEGED FAILURE MODE WAS CONFIRMED AS ALLEGED. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED.¿ 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.

    Additional Manufacturer Narrative · 0

    "WHILE REVIEWING THE COMPLAINT RECORD ASSOCIATED WITH THIS REPORT, IT WAS DISCOVERED THAT THIS EVENT WAS INCORRECTLY FILED AS A SERIOUS INJURY. WE CONFIRMED THAT THIS EVENT DID NOT CAUSE OR CONTRIBUTE TO ANY LIFE-THREATENING CONDITION OR PERMANENT IMPAIRMENT TO THE PATIENT AND DID NOT REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. ADDITIONALLY, A REVIEW OF COMPLAINT HISTORY RECORDS FROM JANUARY 1, 2016 UNTIL TODAY, CONFIRMED THAT THERE HAVE BEEN NO REPORTS OF DEATH OR SERIOUS INJURY ASSOCIATED WITH SIMILAR EVENTS FOR THIS DEVICE FAMILY. FINALLY, THE DEVICE¿S ASSOCIATED RISK DOCUMENTATION CONFIRMED THAT THE HIGHEST POTENTIAL SEVERITY OF HARM FOR THIS HAZARDOUS SITUATION IS A S2. THEREFORE, WE WILL NO LONGER BE FILING REPORTS FOR THIS EVENT TYPE.

    Description of Event or Problem · 0

    SPD TECH REPORTS GETTING A SPLINTER FROM BROKEN CARBON FIBER. CASE TYPE: NO ASSOCIATED PROCEDURE.

    Description of Event or Problem · 0

    SPD TECH REPORTS GETTING A SPLINTER FROM BROKEN CARBON FIBER. 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

    SPD TECH REPORTS GETTING A SPLINTER FROM BROKEN CARBON FIBER. CASE TYPE: NO ASSOCIATED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757765 BOOT ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 210080 201543030601 00848486031879

    Patients

    Seq Age Sex Outcome Treatment
    1 Other