BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET CUP REAMER HANDLE

    MDR report key: 9694876 · Received February 11, 2020

    Report

    Report Number
    3005985723-2020-00081
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 17, 2020
    Report Date
    June 22, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032142
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO B2 AND D2. REPORTED EVENT: IT WAS REPORTED THAT AFTER SURGERY, DURING POST OP X-RAY, IT WAS DISCOVERED AN ITEM HAD BEEN LEFT IN THE PATIENT. AFTER SEARCHING THROUGH EQUIPMENT IT WAS DISCOVERED THAT THE ITEM WAS A SMALL SCREW OFF OF THE MAKO HIP REAMER HANDLE. CASE TYPE: THA. UPDATE (B)(6) 2020: AS REPORTED IN MEDWATCH REPORT "THIS WAS IDENTIFIED VIA X-RAY AFTER THE PROCEDURE WAS COMPLETED. THE TRAYS WERE RE-OPENED, AND IT WAS IDENTIFIED THAT A SCREW WAS MISSING FROM THE MAKO REAMER ARM." INITIAL REPORTER TO THE FDA CONFIRMED THAT THIS PI IS FOR THE SAME EVENT. ON FOLLOW-UP, REP REPORTED "AT THE TIME, THE THOUGHT WAS THAT THE PATIENT WOULD BE BROUGHT BACK IN TO HAVE THE SCREW REMOVED. HOWEVER, AFTER ORDERING POST OP CT SCANS, IT WAS DETERMINED THAT THE SCREW WAS LOCATED IN HARD BONE, AND POSED MINIMAL RISK, SO THE SURGEON DETERMINED IT WOULD BE BEST TO LEAVE THE SCREW ALONE, RATHER THAN REMOVE HARDWARE TO GET TO IT.". THE SCREW REMAINS IN THE PATIENT. PRODUCT EVALUATION AND RESULTS: PRODUCT WAS NOT INSPECTED AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. AS PER THE IMAGE OF THE REAMER HANDLE PROVIDED IN COMMUNICATION LOG THE FAILURE IS CONFIRMED. PRODUCT HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS INDICATE 0 OF 30 DEVICES WERE ACCEPTED INTO FINAL STOCK ON (B)(6) 2017. 17 DEVICES WERE DISPOSITION 'USE AS IS' DATED (B)(6) 2017 AND THE REMAINING 13 DEVICES WERE 'ACCEPT AS PER SPECIFICATION' DATED (B)(6) 2019. THE NON CONFORMANCE IS NOT RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212760, LOT 3880065 SHOWS 0 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE FAILURE IS CONFIRMED AS PER THE IMAGE OF THE REAMER HANDLE PROVIDED IN COMMUNICATION LOG. PRODUCT WAS NOT INSPECTED AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED, THEN THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    AFTER SURGERY, DURING POST OP X-RAY, IT WAS DISCOVERED AN ITEM HAD BEEN LEFT IN THE PATIENT. AFTER SEARCHING THROUGH EQUIPMENT IT WAS DISCOVERED THAT THE ITEM WAS A SMALL SCREW OFF OF THE MAKO HIP REAMER HANDLE. CASE TYPE: THA. UPDATE (B)(6) 2020: AS REPORTED IN MEDWATCH REPORT # 1002600000-2020-8003: "THIS WAS IDENTIFIED VIA X-RAY AFTER THE PROCEDURE WAS COMPLETED. THE TRAYS WERE RE-OPENED, AND IT WAS IDENTIFIED THAT A SCREW WAS MISSING FROM THE MAKO REAMER ARM." INITIAL REPORTER TO THE FDA CONFIRMED THAT THIS PI IS FOR THE SAME EVENT. ON FOLLOW-UP, REP REPORTED "AT THE TIME, THE THOUGHT WAS THAT THE PATIENT WOULD BE BROUGHT BACK IN TO HAVE THE SCREW REMOVED. HOWEVER, AFTER ORDERING POST OP CT SCANS, IT WAS DETERMINED THAT THE SCREW WAS LOCATED IN HARD BONE, AND POSED MINIMAL RISK, SO THE SURGEON DETERMINED IT WOULD BE BEST TO LEAVE THE SCREW ALONE, RATHER THAN REMOVE HARDWARE TO GET TO IT.". THE SCREW REMAINS IN THE PATIENT.

    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

    AFTER SURGERY, DURING POST OP X-RAY, IT WAS DISCOVERED AN ITEM HAD BEEN LEFT IN THE PATIENT. AFTER SEARCHING THROUGH EQUIPMENT IT WAS DISCOVERED THAT THE ITEM WAS A SMALL SCREW OFF OF THE MAKO HIP REAMER HANDLE. CASE TYPE: THA. UPDATE 30/JANUARY/2020: AS REPORTED IN MEDWATCH REPORT # (B)(4): "THIS WAS IDENTIFIED VIA X-RAY AFTER THE PROCEDURE WAS COMPLETED. THE TRAYS WERE RE-OPENED, AND IT WAS IDENTIFIED THAT A SCREW WAS MISSING FROM THE MAKO REAMER ARM." INITIAL REPORTER TO THE FDA CONFIRMED THAT THIS PI IS FOR THE SAME EVENT. ON FOLLOW-UP, REP REPORTED "AT THE TIME, THE THOUGHT WAS THAT THE PATIENT WOULD BE BROUGHT BACK IN TO HAVE THE SCREW REMOVED. HOWEVER, AFTER ORDERING POST OP CT SCANS, IT WAS DETERMINED THAT THE SCREW WAS LOCATED IN HARD BONE, AND POSED MINIMAL RISK, SO THE SURGEON DETERMINED IT WOULD BE BEST TO LEAVE THE SCREW ALONE, RATHER THAN REMOVE HARDWARE TO GET TO IT." THE SCREW REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158411 OFFSET CUP REAMER HANDLE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 212760 3880065 00848486032142

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| O