MAUDE Adverse Event Report: MAKO SURGICAL CORP. SMILEY RETRACTOR; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	210192
Medical Device Problem Codes	Mechanical Problem (1384); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Noticed in cpd that the two right angled retractors in the mako black leg holder set are severely damaged due to being hit by the saw blade.
Additional Manufacturer Narrative
Reported event: customer reported that the two right angled retractors in the mako black leg holder set are severely damaged due to being hit by the saw blade.Device evaluation and results: device evaluation was performed and the smiley retractor event was confirmed.Device history review: review of the device history records indicate 150 devices were manufactured and accepted into final stock on 12-21-17 with no reported discrepancies.Complaint history review: based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding the smiley retractor.There have been no other events for the referenced lot number.Conclusions: the smiley retractor was inspected under a microscope, revealing multiple spots where it was hit by a cutting tool.Material from the surface of the retractor appears to have been removed as a result of contact with the cutting tool.Corrective action/preventive action: as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.
Event or Problem Description
Noticed in cpd that the two right angled retractors in the mako black leg holder set are severely damaged due to being hit by the saw blade.

• Brand Name: SMILEY RETRACTOR
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7687181
• Report Number: 3005985723-2018-00422
• Device Sequence Number: 1316301
• Product Code: OLO
• UDI-Device Identifier: 00848486031916
• UDI-Public: 00848486031916
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 10/09/2018

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
• Operator of Device: No Information
• Device Catalogue Number: 210192
• Device Lot Number: 210192
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 09/30/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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