MAUDE Adverse Event Report: MAKO SURGICAL CORP. BASE BAR ASSM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	210060
Medical Device Problem Codes	Degraded (1153); Material Frayed (1262)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2020
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
F-bar is beginning to splinter.Case type: tka.
Event or Problem Description
F-bar is beginning to splinter.Case type: tka.
Additional Manufacturer Narrative
Update to b2 and d2.Reported issue - f-bar is beginning to splinter.Product inspection - visual inspection of catalog #210060, lot/serial (b)(6) confirms the base bar has splintered along the side of the bar.See image attached.Product history review ¿ review of the device history records for catalog #210060, lot/serial (b)(6) indicates (b)(4) devices were manufactured and all (b)(4) devices were accepted into final stock on 12/27/2018 with no reported discrepancies.Complaint history review ¿ a review of complaints in catsweb and trackwise related to p/n 210060, lot #615603 shows 0 additional complaints related to the failure in this investigation.Conclusion ¿ the event was confirmed.There was splintering noticed along the base bar.

• Brand Name: BASE BAR ASSM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9850208
• Report Number: 3005985723-2020-00166
• Device Sequence Number: 10953853
• 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): 06/22/2020

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: 615603
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 06/22/2020
• 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; Other