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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; STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 209999
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2019
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
Case number: (b)(4) - mps (b)(6) reported inaccurate tka cuts and 'auto arm accuracy' failure.Case type: tka.Update: "any surgical delay? yes, <1hr.Was the case cancelled? no.Was procedure completed successfully? yes.Was procedure completed manually? no - we already made all cuts.Which cuts were inaccurate? system showed all cuts were accurate.How was the cut inaccurate? our system showed all cuts were accurate.What is the estimated discrepancy mentioned in the complaint? (pka - mm) planned for 18mm ending up being 25degrees hyper extended and 28mm gaps.Planned for a 9 poly and ended up putting in a 19.When was the issue noticed (bone preparation or joint assessment)? after bone cuts.Was the planar probe utilized to measure cut accuracy? yes.Are post-op x-rays available? no.".
 
Manufacturer Narrative
Reported event: an event regarding an inaccurate resection involving 3.0 rio® robotic arm mics, catalog: 209999 was reported.It was reported that ¿case number: (b)(4), (b)(6); mps reported inaccurate tka cuts and 'auto arm accuracy' failure.How was the cut inaccurate? our system showed all cuts were accurate.What is the estimated discrepancy mentioned in the complaint? (pka - mm), planned for 18mm ending up being 25degrees hyper extended and 28mm gaps.Planned for a 9 poly and ended up putting in a 19.¿ product evaluation and results: review of the case session files was not performed as case session data was not provided.Field engineer reported: case number: (b)(4), work order: 9b)(4).Problem reproduced? no.Work performed: adjust j4 slightly to bring warning to pass.Clean camera lens, clean hybrid cable connections.Work order deposition: system investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Product history review: review of the device history records associated with rio 745 indicate quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn: 209999 reports similar complaints for tka software / inaccurate resection.The complaints are pr: (b)(4) conclusions: the failure could not be determined as no case session data or logs were provided after three communication attempts were made.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.Corrective action/preventive action: a search of the nc / capa database under device identification pn: 209999 reports no records related to tka software / inaccurate resection.
 
Event Description
Case number: (b)(4), (b)(6); mps (b)(6) reported inaccurate tka cuts and 'auto arm accuracy' failure.Case type: tka.Update: "any surgical delay? yes, 1hr.Was the case cancelled? no.Was procedure completed successfully? yes.Was procedure completed manually? no, we already made all cuts.Which cuts were inaccurate? system showed all cuts were accurate.How was the cut inaccurate? our system showed all cuts were accurate.What is the estimated discrepancy mentioned in the complaint? (pka - mm).Planned for 18mm ending up being 25degrees hyper extended and 28mm gaps.Planned for a 9 poly and ended up putting in a 19.When was the issue noticed (bone preparation or joint assessment)? after bone cuts.Was the planar probe utilized to measure cut accuracy? yes.Are post-op x-rays available? no.
 
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Brand Name
3.0 RIO® ROBOTIC ARM - MICS
Type of Device
STEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key9258406
MDR Text Key180543465
Report Number3005985723-2019-00768
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 04/13/2020
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? Yes
Initial Date Manufacturer Received 10/21/2019
Initial Date FDA Received10/30/2019
Supplement Dates Manufacturer Received03/29/2020
Supplement Dates FDA Received04/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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