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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 209999
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2020
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
During a tha on (b)(6) 2020 we had an issue during surgery.When going into cup reaming the numbers for inclination/version were flip flopped on the screen.(as normally you would see 40inclination and 20version we were seeing 20inclination and 40 version).The robot was still showing numbers in green and allowing the surgeon to ream but numbers were definitely transposed.An attempt to reregister robot as well as all the pelvis was made but same result showed in the cup reaming page.Landmarks and correct operative side were also checked.Had to bail to do hip manually.Case type : tha.Surgical delay: 5-10 minutes, right side.
 
Event Description
During a tha on (b)(6) 2020 we had an issue during surgery.When going into cup reaming the numbers for inclination/version were flip flopped on the screen.(as normally you would see 40inclination and 20version we were seeing 20inclination and 40 version).The robot was still showing numbers in green and allowing the surgeon to ream but numbers were definitely transposed.An attempt to reregister robot as well as all the pelvis was made but same result showed in the cup reaming page.Landmarks and correct operative side were also checked.Had to bail to do hip manually.Case type : tha.Surgical delay: 5-10 minutes, right side.
 
Manufacturer Narrative
Reported event.An event regarding software error involving a mako tha software was reported.The event was not confirmed.Method & results.-product evaluation and results: review of the log/session files has not been completed within 60days of the complaint being opened.The complaint will be closed with an associated risk assessment.Additional failures will be assessed once the log/session file review has been completed.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that rob369 was inspected on 08 oct 2015 and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints in trackwise related to p/n 209999, robot number: rob369 shows 0 similar complaints for tha software - software error.Conclusions: the exact cause of the event could not be determined because insufficient information was made available for evaluation.Review of the log/session files has not been completed within 60days of the complaint being opened.A review of the case session/log data is needed to complete a full investigation for determining root cause.In addition to a review of the log/session, a field service engineer conducts scheduled maintenance on the robot to ensure the robot is system ready.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Device not returned.
 
Manufacturer Narrative
Reported event: an event regarding software error involving a mako tha software was reported.The event was not confirmed.Method & results: -product evaluation and results: review of the case session files was not performed as case session data was not provided.I.D.(b)(6) does not exist or was not made available to the software investigator through life image.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that (b)(6) was inspected on 08 oct 2015 and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints in trackwise related to p/n 209999, robot number: (b)(6) shows 0 similar complaints for tha software - software error.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session/log data are needed to complete the investigation for determining root cause.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text : device not returned.
 
Event Description
During a tha on (b)(6) 2020 we had an issue during surgery.When going into cup reaming the numbers for inclination/version were flip flopped on the screen.(as normally you would see 40 inclination and 20 version we were seeing 20 inclination and 40 version).The robot was still showing numbers in green and allowing the surgeon to ream but numbers were definitely transposed.An attempt to reregister robot as well as all the pelvis was made but same result showed in the cup reaming page.Landmarks and correct operative side were also checked.Had to bail to do hip manually.Case type : tha.Surgical delay: 5-10 minutes, right side.
 
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Brand Name
3.0 RIO ROBOTIC ARM - MICS
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key10951684
MDR Text Key220247072
Report Number3005985723-2020-00377
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030407
UDI-Public00848486030407
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number209999
Device Catalogue Number209999
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/10/2020
Initial Date FDA Received12/05/2020
Supplement Dates Manufacturer Received02/10/2021
04/06/2021
Supplement Dates FDA Received03/04/2021
04/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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