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

Model Number	210060
Medical Device Problem Codes	Degraded (1153); Material Frayed (1262)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	11/25/2019
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
Cpd notified me of splintered long rail on leg positioner.Case type: no associated procedure.
Event or Problem Description
Cpd notified me of splintered long rail on leg positioner.Case type: no associated procedure.
Additional Manufacturer Narrative
Reported issue: cpd notified me of splintered long rail on leg positioner.Product evaluation: visual inspection confirms the base bar has splintered along the bar.See attache product history review: review of the device history records indicate 26 devices were manufactured and accepted into final stock on 02/25/2019.No non-conformances were identified during inspection.Complaint history review: a review of complaints related to p/n 210060, lot 617768 shows no additional complaint(s) related to the failure in this investigation.Conclusion: per (b)(4), 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.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 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: 9510914
• Report Number: 3005985723-2019-00912
• Device Sequence Number: 2777437
• Product Code: OLO
• UDI-Device Identifier: 00848486031855
• UDI-Public: 00848486031855
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 02/03/2020

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 Model Number: 210060
• Device Catalogue Number: 210060
• Device Lot Number: 617768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/04/2020
• 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: Other