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

Catalog Number	210060
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
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
Black rail guide is becoming worn from use, resulting in a rough surface along the carbon and splintering.
Event or Problem Description
Black rail guide is becoming worn from use, resulting in a rough surface along the carbon and splintering.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted.Reported issue: it was reported that the base bar was damaged.Product history review: review of the device history records indicate 64 devices were manufactured and 62 devices were accepted into final stock on 05/24/2017.A review of qt17-05-0097 revealed that the non-conformance is not related to the failure alleged in this compliant.Complaint history review: a review of complaints related to p/n 210060, lot 594361 shows 2 additional complaint(s) related to the failure in this investigation.Complaint pr: (b)(4).Inspection: inspection showed pitting in carbon fiber.Conclusion: the failure mode was confirmed.The hazard/harm combination from this complaint has been previously identified.No additional investigation or specific actions are required.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there has been no nc or capa associated with the product and failure mode reported in this event.

• Brand Name: BASE BAR ASSM
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8412717
• Report Number: 3005985723-2019-00215
• Device Sequence Number: 11319586
• Product Code: OLO
• UDI-Device Identifier: 00848486031855
• UDI-Public: 00848486031855
• 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): 05/28/2019

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: 210060
• Device Lot Number: 594361
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 05/28/2019
• 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