MAUDE Adverse Event Report: MAKO SURGICAL CORP. BAR EXTENSION; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	210070
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2019
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
Carbon rail extension piece chipping along edges.Case type: tka.Update: patient was not under anesthesia.
Event or Problem Description
Carbon rail extension piece chipping along edges.Case type: tka/ update: patient was not under anesthesia.
Additional Manufacturer Narrative
Reported event: it was reported that carbon rail extension piece chipping along edges.Case type: tka.Update: patient was not under anesthesia product evaluation and results: inspection showed small pits in the carbon fiber.Per inspection procedure qip 0005 appendix iv¿ table 4, small pits in the carbon fiber are acceptable.No product problem identified.Product history review: review of the device history records indicate 32 devices were manufactured and accepted into final stock on 01-30-2019 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210070, lot number 615126 shows no additional complaints related to the failure in this investigation.Conclusions: the failure was confirmed via visual inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.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: BAR EXTENSION
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8658751
• Report Number: 3005985723-2019-00399
• Device Sequence Number: 11234928
• Product Code: OLO
• UDI-Device Identifier: 00848486031862
• UDI-Public: 00848486031862
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/09/2019

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: 210070
• Device Lot Number: 615126
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 09/09/2019
• 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