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

Catalog Number	210195
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	06/11/2019
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
Gauged retractor found in cpd while processing trays.Case type: no associated procedure.Update: "the retractors get gauged after performing several mako cases due to the saw blade hitting them during cutting.".
Event or Problem Description
Gauged retractor found in cpd while processing trays.Case type: no associated procedure.Update: "the retractors get gauged after performing several mako cases due to the saw blade hitting them during cutting.".
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Reported event: the retractors get gauged after performing several mako cases due to the saw blade hitting them during cutting.Product evaluation and results: the reported device was confirmed to be a patella retractor, p/n: 210195, lot: 31929.The reported device was confirmed to have a gauged retractor.Product history review: review of the device history records indicate 99 devices were manufactured and inspected on 02-09-2017 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 patella retractor.There have been one other events for the referenced lot number: pr #2080254.Conclusions: the product was inspected and confirmed to have a gauged patella retractor.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: PATELLA RETRACTOR
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8736422
• Report Number: 3005985723-2019-00460
• Device Sequence Number: 11406185
• Product Code: OLO
• UDI-Device Identifier: 00848486031947
• UDI-Public: 00848486031947
• 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): 10/21/2019

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: 210195
• Device Lot Number: 31929
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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