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

Model Number 210080

Device Problem Crack (1135)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

As part of the 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 Description

There is a chip/crack in the boot and is beginning to peel.Not sure when it occurred, but was noticed when tray was opened.Case type: tka.

Manufacturer Narrative

Reported event: there is a chip/crack in the boot and is beginning to peel.Not sure when it occurred, but was noticed when tray was opened.Case type: tka.Product evaluation and results: visual inspection confirms the carbon fiber has splintered on the boot assembly.See attached image.Product history review: review of the device history records for lot 201843012201 indicate 1.(b)(4) devices were manufactured and accepted into final stock on 01-23-2018 with no reported discrepancies.2.(b)(4) devices were manufactured and accepted into final stock on 01-24-2018 with no reported discrepancies.3.(b)(4) devices were manufactured and accepted into final stock on 01-25-2018 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 210080, lot number 201843012201 shows 4 additional complaints related to the failure in this investigation.(b)(4).Conclusions: 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.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.

Event Description

There is a chip/crack in the boot and is beginning to peel.Not sure when it occurred, but was noticed when tray was opened.Case type: tka.

• Brand Name: BOOT ASSEMBLY
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9646690
• MDR Text Key: 177005470
• Report Number: 3005985723-2020-00060
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486031879
• UDI-Public: 00848486031879
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 210080
• Device Catalogue Number: 210080
• Device Lot Number: 201843012201
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 03/09/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other