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

Catalog Number	210192
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2018
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
Gauges in retractor from saw.Case type: no associated procedure.
Event or Problem Description
Gauges in retractor from saw.Case type: no associated procedure.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Reported event: it was reported that the smiley retractor had gauges.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: review of the product history records indicate 150 devices were manufactured under lot no 37831 and accepted into final stock on 12/21/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210192, lot number 37831 shows no additional complaints related to the failure in this investigation.Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.Product was unavailable for inspection as the product was not returned.

• 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: 7970482
• Report Number: 3005985723-2018-00601
• Device Sequence Number: 19276005
• 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): 02/26/2019

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: Health Professional
• Device Catalogue Number: 210192
• Device Lot Number: 37831
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 02/26/2019
• 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