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

Catalog Number	210060
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
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 fiber coating on the base bar is chipped from use.Case type: no associated procedure.
Event or Problem Description
Carbon fiber coating on the base bar is chipped from use.Case type: no associated procedure.
Additional Manufacturer Narrative
Carbon fiber coating on the base bar is chipped from use.Case type: no associated procedure.Product evaluation and results: visual inspection confirms the base bar is chipped.Product history review: review of the device history records indicate 50 devices were manufactured and 50 were accepted into final stock on 07/19/2017.No non-conformances were identified during inspection.Complaint history review: a review of complaints related to p/n 210060, lot 601442 shows no additional complaint(s) related to the failure in this investigation.Conclusion: the event was confirmed.

• 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: 9260072
• Report Number: 3005985723-2019-00784
• Device Sequence Number: 16657701
• Product Code: OLO
• UDI-Device Identifier: 00848486031855
• UDI-Public: 00848486031855
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/07/2020

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: 601442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/07/2020
• 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