MAUDE Adverse Event Report: MAKO SURGICAL CORP. BOOT ASSEMBLY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	210080
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2020
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
Upper part of carbon fiber boot is breaking.Case type: no associated procedure.
Additional Manufacturer Narrative
Upper part of carbon fiber boot is breaking.Product evaluation and results: visual inspection confirms carbon fiber splintering on the boot.See attached image.Product history review: review of the device history records indicate 32 devices were manufactured and accepted into final stock on 06-14-2017 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210080, lot 201743060801 shows 6 additional complaints related to the failure in this investigation.Conclusions: the event was confirmed via visual inspection.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.If additional information is received then the complaint will be reopened.
Event or Problem Description
Upper part of carbon fiber boot is breaking.Case type: no associated procedure.

• Brand Name: BOOT ASSEMBLY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9883849
• Report Number: 3005985723-2020-00179
• Device Sequence Number: 14177389
• Product Code: OLO
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/04/2020

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: 210080
• Device Catalogue Number: 210080
• Device Lot Number: 201743060801
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 05/04/2020
• 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: Hospitalization; Other