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 Code	No Patient Involvement (2645)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event: when the boot was opened for the case the scrub noticed the boot was frayed and sharp.Case type: tka.Product evaluation and results: visual inspection confirms the boot assembly has splintered on the boot.See attached image.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 04/24/2018.No non-conformances were identified during inspection.Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 07/06/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n (b)(4), lot 201843030805 shows 3 additional complaints related to the failure in this investigation, (b)(4).Conclusions: the event was confirmed.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.No additional investigation or specific actions are required.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.
Event or Problem Description
When the boot was opened for the case the scrub noticed the boot was frayed and sharp.Case type: tka.
Additional Manufacturer Narrative
Reported event: when the boot was opened for the case the scrub noticed the boot was frayed and sharp.Case type: tka.Product evaluation and results: visual inspection confirms the boot assembly has splintered on the boot.Product history review: review of the device history records indicate 148 devices were manufactured and accepted into final stock on 04/24/2018.No non-conformances were identified during inspection.Review of the device history records indicate 3 devices were manufactured and accepted into final stock on (b)(6) 2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210080, lot 201843030805 shows 3 additional complaints related to the failure in this investigation, pr (b)(4).Conclusions: the event was confirmed.Per d03391, 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.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.
Event or Problem Description
When the boot was opened for the case the scrub noticed the boot was frayed and sharp.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: 9827489
• Report Number: 3005985723-2020-00150
• Device Sequence Number: 743239
• Product Code: OLO
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 03/30/2020

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: 201843030805
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 03/30/2020
• 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