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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); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2021
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
Mps reported inaccurate cuts and rio registration issues.Mps was having difficulty passing sawblade checkpoint, re-registering robot, and green not going away during bone prep.Mps had to shutdown twice to be able to pass rio registration.Mps confirmed no arrays were bumped.This has occurred on multiple cases.Requested logs.Already spoke with fse.
 
Manufacturer Narrative
Reported event an event regarding inaccurate resection and software error involving a mako unknown application 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.The field service engineer reported: problem reproduced? no trouble shooting notes: none work performed: reported problem ¿ bone not disappearing during bone prep.J6 joint angles inconsistent errors.Observation ¿ unable to reproduce the joint angles inconsistent errors.Action taken ¿ cpci replaced in order to fix the bone not disappearing issue.Original f17 computer transferred to new cpci.J6 encoders cleaned.J6 read head signals optimized.System ready for clinical use work order disposition: system investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that rob481 was inspected on 10 oct 2016 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: rob481 shows 0 similar complaints for unknown application - inaccurate resection.Conclusions: the alleged failure mode was not confirmed by a field service engineer however the cpci was replaced in order to rectify the issue related to the bone not disappearing.To find the root cause of the event further information such as return of the case session/log data are needed to complete the investigation.Successfully completed all checks, verifications, and calibrations.System is ready for clinical use.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
 
Event Description
Mps reported inaccurate cuts and rio registration issues.Mps was having difficulty passing sawblade checkpoint, re-registering robot, and green not going away during bone prep.Mps had to shutdown twice to be able to pass rio registration.Mps confirmed no arrays were bumped.This has occurred on multiple cases.Requested logs.Already spoke with fse.
 
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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 Key11995143
MDR Text Key256770427
Report Number3005985723-2021-00104
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030407
UDI-Public00848486030407
Combination Product (y/n)N
PMA/PMN Number
K141989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number209999
Device Catalogue Number209999
Device Lot NumberROB481
Was Device Available for Evaluation? No
Date Manufacturer Received07/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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