BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET CUP REAMER HANDLE

    MDR report key: 7316023 · Received March 6, 2018

    Report

    Report Number
    3005985723-2018-00136
    Event Type
    Malfunction
    Date Received
    March 6, 2018
    Date of Event
    February 8, 2018
    Report Date
    May 3, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: THE EVENT REPORTED THAT 4 OFFSET REAMER HANDLES AND 4 TRIDENT INLINE-OFFSET IMPACTORS HAD BIOFILM BUILD UP. THE PROCEDURE WAS DELAYED 5 MINUTES. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION SHOWED NO FOREIGN MATTER (BIOFILM) OR DEBRIS. THE YOKES OF THE PROXIMAL U-JOINT WAS FOUND TO BE WORN AT THE EDGES. FUNCTIONAL INSPECTION SHOWED THAT THE DEVICE ROTATED FREELY AND SMOOTHLY. DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS SHOW THAT 22 DEVICES WERE ACCEPTED INTO FINAL STOCK AS "USE AS IS" PER QT 17-07-0031 ON 07/13/2017. THE NONCONFORMANCE WAS UNRELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT HISTORY REVIEW: REVIEW OF COMPLAINTS FOR P/N 212760, L/N 3761448 SHOW NO OTHER COMPLAINT RELATED TO THE FAILURE IN THIS COMPLAINT. CONCLUSION: THE FAILURE WAS NOT CONFIRMED. BIOFILM WAS NOT SEEN WITHIN THE DEVICE. CORRECTIVE ACTION / PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    BIOFILM BUILD UP DISCOVERED INSIDE THE OFFSET REAMERS AND IN LINE OFFSET IMPACTORS. THA PROCEDURE DELAYED MORE THAN 5 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

    BIOFILM BUILD UP DISCOVERED INSIDE THE OFFSET REAMERS AND IN LINE OFFSET IMPACTORS. THA PROCEDURE DELAYED MORE THAN 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160567 OFFSET CUP REAMER HANDLE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 3761448

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization