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

Catalog Number	210192
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2019
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
Smiley retractor damaged and needs replacement.Case type: pka (mics).
Event or Problem Description
Smiley retractor damaged and needs replacement.Case type: pka (mics).
Additional Manufacturer Narrative
Reported event: smiley retractor damaged and needs replacement.Case type: pka (mics).Product evaluation and results: visual inspection: confirmation of smiley retractor damaged.Product history review: review of the product history records indicate 100 devices were manufactured under lot no 31670, and 100 were accepted into final stock on 02/15/2017.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 31670, shows 00 additional complaints related to the failure in this investigation.Conclusions: the event was confirmed.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.

• 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: 9295411
• Report Number: 3005985723-2019-00795
• Device Sequence Number: 1962213
• 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): 12/30/2019

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: 31670
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 12/30/2019
• 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