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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO SURGICAL ARM (CRATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MAKO SURGICAL CORP. RIO SURGICAL ARM (CRATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 207956
Device Problem Failure to Calibrate (2440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
Robot was set up pre surgery checks completed.Patient mako total knee plan was opened for surgeon to review, error message appeared stating burr status mismatch - call service.Exited out of case plan shut down robot to complete a hard reboot.Rehomed robot opened patient plan again error message remained.Repeated hard reboot again and error remained.Patient had already received general anaesthetic prior to error message occurring, surgeon opted to cancel the surgery as they didn¿t want to undertake a navigated or instrumented knee replacement.Patient has been rebooked for surgery in the new year.Surgery postponed until next year.
 
Event Description
Robot was set up pre surgery checks completed.Patient mako total knee plan was opened for surgeon to review, error message appeared stating burr status mismatch - call service.Exited out of case plan shut down robot to complete a hard reboot.Rehomed robot opened patient plan again error message remained.Repeated hard reboot again and error remained.Patient had already received general anaesthetic prior to error message occurring, surgeon opted to cancel the surgery as they didn¿t want to undertake a navigated or instrumented knee replacement.Patient has been rebooked for surgery in the new year.Surgery postponed until next year.
 
Manufacturer Narrative
Update to d2.Reported event: it was reported that robot was set up pre surgery checks completed.Patient mako total knee plan was opened for surgeon to review, error message appeared stating burr status mismatch - call service.Exited out of case plan shut down robot to complete a hard reboot.Rehomed robot opened patient plan again error message remained.Repeated hard reboot again and error remained.Patient had already received general anaesthetic prior to error message occurring, surgeon opted to cancel the surgery as they didn¿t want to undertake a navigated or instrumented knee replacement.Patient has been rebooked for surgery in the new year.Surgery postponed until next year product evaluation and results: 1.As per the image provided in the communication log the alleged failure is confirmed.2.As per the communication with technical support no work order is available in service max and also no product is returned for inspection.Product history review: a review of device history records shows that rob276 was inspected and accepted into stock on 5/22/2014 and was handled via npr.A review of the data revealed that the non-conformances is not related to the failure alleged in this complaint.Complaint history review: a review of complaints in trackwise related to rob276 shows no additional complaints related to the failure in this investigation.Conclusions: the failure is confirmed via inspection as per the image provided in the communication log the alleged failure is confirmed.As per the communication with technical support no work order is available in service max and also no product is returned for inspection.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.
 
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Brand Name
RIO SURGICAL ARM (CRATED)
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key9559746
MDR Text Key175047682
Report Number3005985723-2020-00006
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K170593
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number207956
Device Lot NumberROB276
Was Device Available for Evaluation? No
Date Manufacturer Received07/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age91 YR
Patient Weight85
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