BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE ANGLED SAGITAL SAW

    MDR report key: 9359792 · Received November 21, 2019

    Report

    Report Number
    3005985723-2019-00816
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 25, 2019
    Report Date
    March 11, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032128
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT ALL CASE DAY THE SCRUB NURSE REPORTED A GREY GREASY SUBSTANCE RUBBING OFF ONTO GLOVES FROM THE ATTACHMENT PIECES. WE HAVE THREE COMPLETE SETS AND ALL SETS HAD TO BE RE-RUN AND FLASHED ALL DAY AND STILL CAME UP WITH THE GREY GREASE. THE SCRUB NURSE DID NOT WANT TO ACCEPT THIS ONTO THE BACK TABLE AS NO ONE COULD DEFINITIVELY STATE WHETHER OR NOT IT WAS STERILE. THE OR MANAGER IS WONDERING A COUPLE THINGS. ONE, IS THIS HAPPENING AT OTHER ACCOUNTS? IF SO, HOW ARE THEY NAVIGATING THIS? TWO, IS THERE ANYTHING IN WRITING THAT STATES THAT WHEN THIS DOES OCCUR, IT IS STERILE AND OKAY TO PROCEED WITH THE CASE? ACCORDING TO THE MANAGER, IF THERE WAS SOMETHING IN WRITING THE SCRUB NURSE AND TECHS WOULDN¿T BE ABLE TO REFUSE TAKING THE ATTACHMENTS AT THEIR OWN DISCRETION. LOOKING FOR SOME DIRECTION FOR THE MANAGEMENT AND STERILIZATION DEPARTMENT. PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. THE FAILURE CANNOT BE DETERMINED FROM THE IMAGES PROVIDED IN THE COMMUNICATION LOG. PRODUCT HISTORY REVIEW: 1. REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE (B)(4) WERE MANUFACTURED AND 39 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 01/10/2017. REVIEW OF QT 17-01-0017 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. 2. REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE (B)(4) WERE REWORKED AND ALL WERE REJECTED ON 05/18/2017. REVIEW OF QT 17-05-0073 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. 3. REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE (B)(4) WERE REWORKED AND ALL WERE REJECTED ON 07/18/2017. REVIEW OF QT 17-07-0047 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. 4. REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE (B)(4) WERE REWORKED AND 1 WAS ACCEPTED INTO STOCK ON 08/30/2017. REVIEW OF QT 17-08-0123 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. 5. REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE(B)(4) WERE REWORKED AND ACCEPTED INTO FINAL STOCK ON 09/02/2017. 6. REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE (B)(4) WERE REWORKED AND 2 WERE ACCEPTED INTO STOCK ON 09/02/2017. REVIEW OF QT 17-09-0001 REVEALED THAT THE NON-CONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 212480, LOT 35021216 SHOWS 1 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLIANT IS (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 NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THIS PI IS FOR CASE 2 OF 3. ALL CASE DAY THE SCRUB NURSE REPORTED A GREY GREASY SUBSTANCE RUBBING OFF ONTO GLOVES FROM THE ATTACHMENT PIECES. WE HAVE THREE COMPLETE SETS AND ALL SETS HAD TO BE RE-RUN AND FLASHED ALL DAY AND STILL CAME UP WITH THE GREY GREASE. THE SCRUB NURSE DID NOT WANT TO ACCEPT THIS ONTO THE BACK TABLE AS NO ONE COULD DEFINITIVELY STATE WHETHER OR NOT IT WAS STERILE. THE OR MANAGER IS WONDERING A COUPLE THINGS. ONE, IS THIS HAPPENING AT OTHER ACCOUNTS? IF SO, HOW ARE THEY NAVIGATING THIS? TWO, IS THERE ANYTHING IN WRITING THAT STATES THAT WHEN THIS DOES OCCUR, IT IS STERILE AND OKAY TO PROCEED WITH THE CASE? ACCORDING THE MANAGER, IF THERE WAS SOMETHING IN WRITING THE SCRUB NURSE AND TECHS WOULDN¿T BE ABLE TO REFUSE TAKING THE ATTACHMENTS AT THEIR OWN DISCRETION. LOOKING FOR SOME DIRECTION FOR THE MANAGEMENT AND STERILIZATION DEPARTMENT. UPDATE 12/NOVEMBER/2019 (B)(6): AS REPORTED BY REP: "THIS HAS PROBABLY HAPPENED IN ALL THREE TKA CASES THAT DAY. THE PATIENTS WERE IN THE ROOM BUT NOT QUITE COMPLETELY UNDER. NOT SURE HOW YOU WOULD CONSIDER THAT IN TERMS OF BEING ¿UNDER ANESTHESIA¿ AS THEY ONLY REALLY DO SPINALS AT THIS HOSPITAL. THE SOLUTION HASN¿T BEEN RESOLVED. THEY ARE WAITING FOR OFFICIAL WORD, BUT AS FOR NOW IF THEY CONTINUE TO COME UP WITH THE GREASE OR GRAY STUFF THEY ARE DEEMING THEM UNSTERILE AND REJECTING THEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. I DO NOT NEED REPLACEMENTS UNLESS YOU DEEM IT NECESSARY. " CASE TYPE UNKNOWN.

    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

    THIS PI IS FOR CASE 2 OF 3. ALL CASE DAY THE SCRUB NURSE REPORTED A GREY GREASY SUBSTANCE RUBBING OFF ONTO GLOVES FROM THE ATTACHMENT PIECES. WE HAVE THREE COMPLETE SETS AND ALL SETS HAD TO BE RE-RUN AND FLASHED ALL DAY AND STILL CAME UP WITH THE GREY GREASE. THE SCRUB NURSE DID NOT WANT TO ACCEPT THIS ONTO THE BACK TABLE AS NO ONE COULD DEFINITIVELY STATE WHETHER OR NOT IT WAS STERILE. THE OR MANAGER IS WONDERING A COUPLE THINGS. ONE, IS THIS HAPPENING AT OTHER ACCOUNTS? IF SO, HOW ARE THEY NAVIGATING THIS? TWO, IS THERE ANYTHING IN WRITING THAT STATES THAT WHEN THIS DOES OCCUR, IT IS STERILE AND OKAY TO PROCEED WITH THE CASE? ACCORDING THE MANAGER, IF THERE WAS SOMETHING IN WRITING THE SCRUB NURSE AND TECHS WOULDN¿T BE ABLE TO REFUSE TAKING THE ATTACHMENTS AT THEIR OWN DISCRETION. LOOKING FOR SOME DIRECTION FOR THE MANAGEMENT AND STERILIZATION DEPARTMENT. UPDATE 12/NOVEMBER/2019 WG: AS REPORTED BY REP: "THIS HAS PROBABLY HAPPENED IN ALL THREE TKA CASES THAT DAY. THE PATIENTS WERE IN THE ROOM BUT NOT QUITE COMPLETELY UNDER. NOT SURE HOW YOU WOULD CONSIDER THAT IN TERMS OF BEING ¿UNDER ANESTHESIA¿ AS THEY ONLY REALLY DO SPINALS AT THIS HOSPITAL. THE SOLUTION HASN¿T BEEN RESOLVED. THEY ARE WAITING FOR OFFICIAL WORD, BUT AS FOR NOW IF THEY CONTINUE TO COME UP WITH THE GREASE OR GRAY STUFF THEY ARE DEEMING THEM UNSTERILE AND REJECTING THEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. I DO NOT NEED REPLACEMENTS UNLESS YOU DEEM IT NECESSARY. " CASE TYPE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150367 2.7 DEGREE ANGLED SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 212480 3500469 / 35021216 00848486032128

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization