MAUDE Adverse Event Report: MAKO SURGICAL CORP. ARRAY- RIO BASE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	112227
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Case number: (b)(4), mps, (b)(6), reported robot off cutting to 5mm deep.Reverted to manual.Case type: tka surgical delay: 5 hours.Surgery was not completed robotically.Update: "was there patient involvement? any patient harm? yes need to revert to manual and use 5mm distal augments.Any surgical delay? 5hours.Was the case cancelled? no.Was procedure completed successfully? yes but not to plan.Was procedure completed manually? yes.Was the patient under anesthesia at the time of the issue? yes.Which cuts were inaccurate? only one cut preformed and the distal femur.How was the cut inaccurate? 5mm deep.What is the estimated discrepancy mentioned in the complaint? (pka - mm) 5mm.When was the issue noticed? bone preparation.Was the planar probe utilized to measure cut accuracy? yes.Are post-op x-rays available? no.".
Event or Problem Description
Case number: (b)(4), rob523: mps, tara brett, reported robot off cutting to 5mm deep.Reverted to manual.Case type: tka.Surgical delay: 5 hours.Surgery was not completed robotically.Update: "was there patient involvement? any patient harm? yes need to revert to manual and use 5mm distal augments.Any surgical delay? 5hours.Was the case cancelled? no.Was procedure completed successfully? yes but not to plan.Was procedure completed manually? yes.Was the patient under anesthesia at the time of the issue? yes.Which cuts were inaccurate? only one cut preformed and the distal femur.How was the cut inaccurate? 5mm deep.What is the estimated discrepancy mentioned in the complaint? (pka - mm) 5mm when was the issue noticed? bone preparation.Was the planar probe utilized to measure cut accuracy? yes.Are post-op x-rays available? no.".
Additional Manufacturer Narrative
It has been confirmed that stryker reference numbers 3005985723-2019-00736 and 3005985723-2019-00739 are related to the same procedure and patient that were received and entered to our complaint system from two different sources.This event, 3005985723-2019-00786, is being cancelled as it is a duplicate event.

• Brand Name: ARRAY- RIO BASE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9260158
• Report Number: 3005985723-2019-00786
• Device Sequence Number: 1879619
• Product Code: OLO
• UDI-Device Identifier: 00848486017446
• UDI-Public: 00848486017446
• Combination Product (Y/N): N
• PMA/510(K) Number: K142530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 112227
• Device Lot Number: 19050116
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 69 YR