BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET CUP REAMER HANDLE

    MDR report key: 8795410 · Received July 16, 2019

    Report

    Report Number
    3005985723-2019-00518
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Date of Event
    July 9, 2019
    Report Date
    September 17, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032142
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT AFTER REAMING A SMALL SCREW WAS FOUND IN THE ACETABULUM. THE SCREW WAS RECOVERED AND THE REAMER WAS INSPECTED. THE SCREW WAS FOUND TO COME FROM THE REAMER AND TWO OTHER SCREWS WERE DISCOVERED TO BE MISSING FROM THE REAMER. AN X-RAY WAS PERFORMED TO ENSURE THEY WERE NOT IN THE PATIENT WHICH THEY WERE NOT. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS NOT EVALUATED AS THE PRODUCT WAS UNAVAILABLE FOR INSPECTION. PRODUCT HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS INDICATE 0 OF (B)(4) DEVICES WERE ACCEPTED INTO FINAL STOCK ON 02/08/2018. NON-CONFORMANCES WERE HANDLED BY QT 18-02-0028 AND (B)(4) PARTS WERE DISPOSITIONED "USE-AS-IS" AS THE PARTS WERE NOT OUT OF SPECIFICATION. THE NONCONFORMANCE WAS UNRELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE RELATED TO P/N 212760, LOT NUMBER 3855372 SHOWS 01 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT INVESTIGATION(S) (B)(4). CONCLUSIONS: THE FAILURE COULD NOT BE DETERMINED AS THE PRODUCT WAS NOT AVAILABLE FOR 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 NCS OR CAPAS ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. PRODUCT WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    AFTER REAMING A SMALL SCREW WAS FOUND IN THE ACETABULUM. THE SCREW WAS RECOVERED AND THE REAMER WAS INSPECTED. THE SCREW WAS FOUND TO COME FROM THE REAMER AND TWO OTHER SCREWS WERE DISCOVERED TO BE MISSING FROM THE REAMER. AN X-RAY WAS PERFORMED TO ENSURE THEY WERE NOT IN THE PATIENT WHICH THEY WERE NOT. CASE TYPE: THA. SURGICAL DELAY: 15 MINUTES.

    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 REAMING A SMALL SCREW WAS FOUND IN THE ACETABULUM. THE SCREW WAS RECOVERED AND THE REAMER WAS INSPECTED. THE SCREW WAS FOUND TO COME FROM THE REAMER AND TWO OTHER SCREWS WERE DISCOVERED TO BE MISSING FROM THE REAMER. AN X-RAY WAS PERFORMED TO ENSURE THEY WERE NOT IN THE PATIENT WHICH THEY WERE NOT. CASE TYPE: THA. SURGICAL DELAY: =15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590029 OFFSET CUP REAMER HANDLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 3855372 00848486032142

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization