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	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 supplemental report will be submitted when additional information becomes available.
Event or Problem Description
Stryker leg holder has abrasion on the top of the leg holder and the hospital is no longer able to sterilize it properly and spd requests a replacement.Case type: no associated procedure.Update: as per closed duplicate pi (b)(4): "as reported: "hospital requested a replacement mako knee holder boot due to damage.It is chipped/ delaminated." spoke to rep.No associated procedure.No further information will be released by the hospital or surgeon.'.
Event or Problem Description
Stryker leg holder has abrasion on the top of the leg holder and the hospital is no longer able to sterilize it properly and spd requests a replacement.Case type: no associated procedure.Update: as per closed duplicate (b)(4): "as reported: "hospital requested a replacement mako knee holder boot due to damage.It is chipped/ delaminated." spoke to rep.No.Associated procedure.No further information will be released by the hospital or surgeon.'.
Additional Manufacturer Narrative
Reported event: stryker leg holder has abrasion on the top of the leg holder and the hospital is no longer able to sterilize it properly and spd requests a replacement.Case type: no associated procedure update: as per closed duplicate (b)(4): "as reported: "hospital requested a replacement mako knee holder boot due to damage.It is chipped/ delaminated." spoke to rep.No associated procedure.No further information will be released by the hospital or surgeon.'.Product evaluation and results: visual inspection confirms the boot assembly has splintered along the edges of the boot.See attached image for visual confirmation.Product history review: review of the device history records cannot be conducted as the lot number is incorrect.Complaint history review: review of the complaint history records cannot be conducted as the lot number is incorrect.Conclusions: 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.The failure was confirmed via visual inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.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.

• 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: 9722480
• Report Number: 3005985723-2020-00091
• Device Sequence Number: 14270427
• Product Code: OLO
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/22/2020

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: 210080
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 04/22/2020
• 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