BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7 DEGREE ANGLED SAGITAL SAW

    MDR report key: 8205126 · Received December 28, 2018

    Report

    Report Number
    3005985723-2018-00802
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 19, 2018
    Report Date
    May 30, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486032128
    PMA / PMN Number
    K143752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: STRYKER REP REPORTED THAT THE PART FAILED DURING SURGERY. TKA WAS COMPLETED USING TRADITIONAL INSTRUMENTATION SURGICAL DELAY 50 MINUTES. UPDATE: MR (B)(6) UNDERTOOK HIS FIRST EVER TKA EARLIER TODAY. THE CASE WAS GOING TO PLAN UNTIL THEY WERE PREPARING TO EXECUTE BONE RESECTIONS WITH THE MAKO. WHEN ENGAGING POWER ON THE MICS HANDPIECE THERE WAS A QUIET SOUND COMING FROM THE MICS HANDPIECE RATHER THAN THE USUAL LOUD SAW NOISE. MAKO SPECIALIST TROUBLE SHOT THE MICS AND ALSO THE OFFSET SAW ATTACHMENT (212480). SPECIALIST TRIED THE STRAIGHT SAW ATTACHMENT, AND THIS FUNCTIONED PROPERLY. THEN TRIED A NEW MICS POWER TOOL WITH THE SUSPECT OFFSET SAW AND AGAIN THIS FAILED. DUE TO HOSPITAL FACTORS THE SECOND ATTACHMENT KIT WAS UNAVAILABLE SO THE DECISION WAS MADE TO CONVERT TO A MANUAL (DEPUY PFC) KNEE REPLACEMENT. THIS SAW ATTACHMENT HAS ONLY EVER BEEN USED ONCE BEFORE. SURGICAL DELAY OF 50 MINUTES. NOT AWARE OF ANY FOLLOW UP INTERVENTION OR ADVERSE PATIENT OUTCOMES. TKA WAS COMPLETED USING TRADITIONAL INSTRUMENTATION FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. VISUAL INSPECTION: VISUAL INSPECTION COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. MATERIAL ANALYSIS: MATERIAL ANALYSIS COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY REVIEW: PRODUCT HISTORY REVIEW RESPECTIVELY SHOWS THE NUMBER OF DEVICES MANUFACTURED, DEVICES THAT FAILED INSPECTION, AND THEIR NC/NPR/QT NUMBERS IF APPLICABLE. DATE INSPECTED: 05-09-2018, DEVICES MANUFACTURED: 42, DEVICES FAILED INSPECTION: 13, NC/NPR/QT NUMBERS: QT18-05-0030. PRODUCT HISTORY REVIEW SHOWS THE NON-CONFORMANCE(S) IS/ARE NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N: 212480, LOT NUMBER: 35060118 SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINTS RELATED TO P/N: 212480 WILL BE TRACKED BY TREND REQUEST# 1191. CONCLUSION: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. 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

    STRYKER REP REPORTED THAT THE PART FAILED DURING SURGERY. TKA WAS COMPLETED USING TRADITIONAL INSTRUMENTATION SURGICAL DELAY 50 MINUTES UPDATE: MR (B)(6) UNDERTOOK HIS FIRST EVER TKA EARLIER TODAY. THE CASE WAS GOING TO PLAN UNTIL THEY WERE PREPARING TO EXECUTE BONE RESECTIONS WITH THE MAKO. WHEN ENGAGING POWER ON THE MICS HANDPIECE THERE WAS A QUIET SOUND COMING FROM THE MICS HANDPIECE RATHER THAN THE USUAL LOUD SAW NOISE. MAKO SPECIALIST TROUBLE SHOT THE MICS AND ALSO THE OFFSET SAW ATTACHMENT (212480). SPECIALIST TRIED THE STRAIGHT SAW ATTACHMENT, AND THIS FUNCTIONED PROPERLY. THEN TRIED A NEW MICS POWER TOOL WITH THE SUSPECT OFFSET SAW AND AGAIN THIS FAILED. DUE TO HOSPITAL FACTORS THE SECOND ATTACHMENT KIT WAS UNAVAILABLE SO THE DECISION WAS MADE TO CONVERT TO A MANUAL (DEPUY PFC) KNEE REPLACEMENT. THIS SAW ATTACHMENT HAS ONLY EVER BEEN USED ONCE BEFORE. SURGICAL DELAY OF 50 MINUTES. NOT AWARE OF ANY FOLLOW UP INTERVENTION OR ADVERSE PATIENT OUTCOMES. TKA WAS COMPLETED USING TRADITIONAL INSTRUMENTATION.

    Description of Event or Problem · 0

    STRYKER REP REPORTED THAT THE PART FAILED DURING SURGERY. TKA WAS COMPLETED USING TRADITIONAL INSTRUMENTATION SURGICAL DELAY 50 MINUTES. MR (B)(6) UNDERTOOK HIS FIRST EVER TKA EARLIER TODAY. THE CASE WAS GOING TO PLAN UNTIL THEY WERE PREPARING TO EXECUTE BONE RESECTIONS WITH THE MAKO. WHEN ENGAGING POWER ON THE MICS HANDPIECE THERE WAS A QUIET SOUND COMING FROM THE MICS HANDPIECE RATHER THAN THE USUAL LOUD SAW NOISE. MAKO SPECIALIST TROUBLE SHOT THE MICS AND ALSO THE OFFSET SAW ATTACHMENT (212480). SPECIALIST TRIED THE STRAIGHT SAW ATTACHMENT, AND THIS FUNCTIONED PROPERLY. THEN TRIED A NEW MICS POWER TOOL WITH THE SUSPECT OFFSET SAW AND AGAIN THIS FAILED. DUE TO HOSPITAL FACTORS THE SECOND ATTACHMENT KIT WAS UNAVAILABLE SO THE DECISION WAS MADE TO CONVERT TO A MANUAL (DEPUY PFC) KNEE REPLACEMENT. THIS SAW ATTACHMENT HAS ONLY EVER BEEN USED ONCE BEFORE. SURGICAL DELAY OF 50 MINUTES. NOT AWARE OF ANY FOLLOW UP INTERVENTION OR ADVERSE PATIENT OUTCOMES. TKA WAS COMPLETED USING TRADITIONAL INSTRUMENTATION.

    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

    STRYKER REP REPORTED THAT THE PART FAILED DURING SURGERY. TKA WAS COMPLETED USING TRADITIONAL INSTRUMENTATION. SURGICAL DELAY 50 MINUTES. UPDATE: MR (B)(6) UNDERTOOK HIS FIRST EVER TKA EARLIER TODAY. THE CASE WAS GOING TO PLAN UNTIL THEY WERE PREPARING TO EXECUTE BONE RESECTIONS WITH THE MAKO. WHEN ENGAGING POWER ON THE MICS HANDPIECE THERE WAS A QUIET SOUND COMING FROM THE MICS HANDPIECE RATHER THAN THE USUAL LOUD SAW NOISE. MAKO SPECIALIST TROUBLESHOT THE MICS AND ALSO THE OFFSET SAW ATTACHMENT (212480). SPECIALIST TRIED THE STRAIGHT SAW ATTACHMENT, AND THIS FUNCTIONED PROPERLY. THEN TRIED A NEW MICS POWER TOOL WITH THE SUSPECT OFFSET SAW AND AGAIN THIS FAILED. DUE TO HOSPITAL FACTORS THE SECOND ATTACHMENT KIT WAS UNAVAILABLE SO THE DECISION WAS MADE TO CONVERT TO A MANUAL (DEPUY PFC) KNEE REPLACEMENT. THIS SAW ATTACHMENT HAS ONLY EVER BEEN USED ONCE BEFORE. NOT AWARE OF ANY FOLLOW UP INTERVENTION OR ADVERSE PATIENT OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042319 2.7 DEGREE ANGLED SAGITAL SAW STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 3503178/35060118 00848486032128

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization