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

Catalog Number	210192
Medical Device Problem Codes	Dent in Material (2526); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2019
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
Smiley retractor badly damaged due to saw blade interaction during tka cuts case type: tka.
Event or Problem Description
Smiley retractor badly damaged due to saw blade.Interaction during tka cuts.Case type: tka.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Smiley retractor badly damaged due to saw blade interaction during tka cuts.Device evaluation and results: device evaluation was performed and the smiley retractor event was confirmed.Device history review: a review of the product history records was attempted for the reported indicate.Device lot no: 29410, but no records or non-conformances were identified during review.Complaint history review: a review of complaints in catsweb and trackwise related to p/n: 206693, lot number: 29410 shows 02 additional complaints related to the failure in this investigation.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.

• 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: 8946567
• Report Number: 3005985723-2019-00613
• Device Sequence Number: 13509586
• 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): 11/26/2019

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: 29410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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