MAUDE Adverse Event Report: MAKO SURGICAL CORP. BOOT ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Model Number	210080
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2020
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
It was noticed that the carbon boot was cracking/splintering along a top lip during pre-surgery check.Case type: tka.
Additional Manufacturer Narrative
Reported issue ¿ it was noticed that the carbon boot was cracking/splintering along a top lip during pre-surgery check.Case type: tka.Product identification ¿ the returned device was confirmed to be a mako boot assembly catalog# 210080, ln: 201743082802.Product inspection ¿ visual inspection confirmed the top of the boot has carbon splintering.See attached evidence.Product history review ¿ review of the device history records indicate (b)(4) device(s) were manufactured under catalog# 210080, ln: 201743082802 and all devices were accepted into final stock on 02 dec 2017.No non-conformance was found during the inspection.Review of the device history records indicate (b)(4) device(s) were manufactured under catalog# 210080, ln: 201743082802 and all devices were accepted into final stock on 01 aug 2017.No non-conformance was found during the inspection.Conclusion - the event was confirmed.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
It was noticed that the carbon boot was cracking/splintering along a top lip during pre-surgery check.Case type: tka.

• Brand Name: BOOT ASSEMBLY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9911560
• Report Number: 3005985723-2020-00188
• Device Sequence Number: 3131600
• Product Code: OLO
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/11/2020

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: 201743092901
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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
• Patient Age: 44 YR