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	09/03/2019
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 fibers are sticking out.Case type: tka.
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections mfr name, city & state, mfr site, premarket identification, type of report, follow up type, device evaluated by mfr, adverse event problem, additional narrative based on the results of investigation.Carbon fibers are sticking out.Case type: tka.Product evaluation and results: visual inspection: confirm carbon fibers visible on the bar extension.Product history review: review of the device history records indicate (b)(4) devices were manufactured and (b)(4) device accepted into final stock on (b)(6) 2017.Complaint history review: a review of complaints related to p/n: 210070, lot number: 601589, shows 00, additional complaint(s) related to the failure in this investigation.Conclusion: the event is confirmed.Per d03391, preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.No additional investigation or specific actions are required.
Event or Problem Description
Carbon fibers are sticking out.Case type: tka.

• 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: 8974447
• Report Number: 3005985723-2019-00651
• Device Sequence Number: 3294666
• Product Code: OLO
• UDI-Device Identifier: 00848486031862
• UDI-Public: 00848486031862
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/19/2019

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: 601589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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