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

Model Number	210080
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported issue - noticed during decontamination process, that the carbon fibers at top portion of the boot appear to be fraying/splintering.Boot needs replacement.Product inspection ¿ visual inspection confirmed there were carbon fiber splinters on the top portion of the boot.Product history review - a review of the product history records for catalog #210080 lot no 210743092602 was attempted, but no results were found.Complaint history review ¿ a review of complaints in catsweb and trackwise related to p/n 210080, lot number 210743092602 was attempted, but no results were found.Nc/capa history review - 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.Conclusion ¿ 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.
Event or Problem Description
Noticed during decontamination process.Carbon fibers at top portion of boot appear to be fraying/splintering.Boot needs replacement.Case type: no associated procedure.
Event or Problem Description
Noticed during decontamination process.Carbon fibers at top portion of boot appear to be fraying/splintering.Boot needs replacement.Case type: no associated procedure.
Additional Manufacturer Narrative
Reported issue: noticed during decontamination process.Carbon fibers at top portion of boot appear to be fraying/splintering.Boot needs replacement.Product inspection: visual inspection confirmed there were carbon fiber splinters on the top portion of the boot.Product history review: a review of the product history records for catalog #210080 lot no 210743092602 was attempted, but no results were found.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210080, lot number 210743092602 was attempted, but no results were found.Nc/capa history review: 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.Conclusion ¿ 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.

• 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: 9836935
• Report Number: 3005985723-2020-00156
• Device Sequence Number: 19220208
• Product Code: OLO
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/26/2020

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: 210743092602
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 03/07/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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