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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 Failure to Calibrate (2440); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
It was reported the arm dropped from 90/90 position after rio setup.Mps stated arm dropped about 3 feet.They were able to complete the case but cup placement was off.After the case the mps was trying to place the arm in the holster position but j5 was stuck and then it spun quickly in the other direction.Mps confirm pre-surgery checks passed after the case.
 
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.
 
Manufacturer Narrative
Reported event: mps reported arm dropped from 90/90 position after rio setup.Mps stated arm dropped about 3 feet.They were able to complete the case but cup placement was off.After the case the mps was trying to place the arm in the holster position but j5 was stuck and then it spun quickly in the other direction.Mps confirm pre-surgery checks passed after the case.Device evaluation and results: problem reproduced? no.Work performed : reported problem ¿ arm dropped from 90/90 position after rio setup.Observation ¿inspected and tested robot for damage.Action taken ¿system passed all tested, tensioned j5 & j6 cables, and performed a pm service.System ready for clinical use.Work order deposition system investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Device history review: a review of device history records shows that the robot was inspected and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints shows 0 additional complaints related to the failure in this investigation.Conclusions: the failure was not replicated via inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
 
Event Description
It was reported the arm dropped from 90/90 position after rio setup.Mps stated arm dropped about 3 feet.They were able to complete the case but cup placement was off.After the case the mps was trying to place the arm in the holster position but j5 was stuck and then it spun quickly in the other direction.Mps confirm pre-surgery checks passed after the case.
 
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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
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood WD6 3-SJ
UK   WD6 3SJ
2082386500
MDR Report Key12825020
MDR Text Key284966589
Report Number3005985723-2021-00186
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030407
UDI-Public00848486030407
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
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
Is the Reporter a Health Professional? No
Date Manufacturer Received01/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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