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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 Measurement (1383); Poor Quality Image (1408)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2019
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
When trying to use a segmented tka plan from the tda program, there was a substantial amount of unexplained ridges and imperfections in the bone model.The case/plan was never used and only looked at and reviewed on my laptop.Plan was then resubmitted and segmented properly for a tka.Case type: tka.
 
Manufacturer Narrative
Update to d2.Reported event: it was reported that ¿when trying to use a segmented tka plan from the tda program, there was a substantial amount of unexplained ridges and imperfections in the bone model.The case/plan was never used and only looked at and reviewed on my laptop.Plan was then resubmitted and segmented properly for a tka.¿.Product evaluation and results: review of the case session files was not performed as the event occurred prior to the case.It was also noted that although there are visual differences between tda-created bone models vs livewire-created bone models, the tda application was manufactured to specification and verified for bone registration accuracy.In addition, the surgical case would not be impacted if the tda-created bone model was used instead of the livewire-created bone model.This issue is only a visual preference and has no impact on the intended use of the system.Product history review: review of the device history records associated with (b)(4) indicate that on 28/06/2018 quality inspection procedures were completed with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209999 shows no additional complaints related to the failure in this investigation.One additional complaint was raised along with this complaint.Conclusions: the reported event was confirmed.Review of the case session files was not performed as the event occurred prior to the case.It was also noted as part of nc that although there are visual differences between tda-created bone models vs livewire-created bone models, the tda application was manufactured to specification and verified for bone registration accuracy.In addition, the surgical case would not be impacted if the tda-created bone model was used instead of the livewire-created bone model.This issue is only a visual preference and has no impact on the intended use of the system.The tka case was re-segmented using livewire and provided to the mako product specialist for the associated surgery.Capa will address the root cause(s) and corrective actions to prevent this issue from recurring.No additional investigation or specific actions are required at this time.If additional information is received such as the session files, then the complaint will be reopened.
 
Event Description
When trying to use a segmented tka plan from the tda program, there was a substantial amount of unexplained ridges and imperfections in the bone model.The case/plan was never used and only looked at and reviewed on my laptop.Plan was then resubmitted and segmented properly for a tka.Case type: tka.
 
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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 Key9571384
MDR Text Key191003381
Report Number3005985723-2020-00010
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
Report Date 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number209999
Device Catalogue Number209999
Device Lot NumberROB753
Was Device Available for Evaluation? No
Date Manufacturer Received06/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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