MAUDE Adverse Event Report: MAKO SURGICAL CORP. BOOT ASSEMBLY; OPERATING ROOM ACCESSORIES TABLE TRAY

Model Number	210080
Medical Device Problem Codes	Fracture (1260); Material Frayed (1262); Sharp Edges (4013)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2020
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 supplement al report will be submitted when additional information becomes available.
Event or Problem Description
A small piece of the boot assembly has cracked off creating a sharp edge on the carbon fiber.Case type: tka.
Additional Manufacturer Narrative
Update to b2, d2, executive summary and common device name.Reported event: a small piece of the boot assembly has cracked off creating a sharp edge on the carbon fiber.Case type: tka.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection a capa has been raised for the same.Product history review: review of the device history records cannot be conducted as the lot number is unknown.Complaint history review: review of the complaint history records cannot be conducted as the lot number is unknown.Conclusions: 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 could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
A small piece of the boot assembly has cracked off creating a sharp edge on the carbon fiber.Case type: tka.

• Brand Name: BOOT ASSEMBLY
• Common Device Name: OPERATING ROOM ACCESSORIES TABLE TRAY
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9694884
• Report Number: 3005985723-2020-00083
• Device Sequence Number: 16907403
• Product Code: FWZ
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: No Information
• Device Model Number: 210080
• Device Catalogue Number: 210080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 02/11/2020
• 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