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

Model Number 210080

Device Problems Degraded (1153); Material Frayed (1262)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2019

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

Boot starting to fray and cause loose shavings.Case type: tka.Patient under anesthesia.

Event Description

Boot starting to fray and cause loose shavings.Case type: tka.Patient under anesthesia.

Manufacturer Narrative

Reported event: boot starting to fray and cause loose shavings.Case type: tka.Product evaluation and results: visual inspection showed splintering in the carbon fiber.Product history review: review of the device history records for lot 201843012201 indicate 1.(b)(4)were manufactured and accepted into final stock on 01-23-2018 with no reported discrepancies.2.(b)(4)were manufactured and accepted into final stock on 01-24-2018 with no reported discrepancies.3.(b)(4)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 3 additional complaints related to the failure in this investigation.Pr id (b)(4).Conclusions: 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
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9583881
• MDR Text Key: 181198537
• Report Number: 3005985723-2020-00025
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• 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
• Date Manufacturer Received: 02/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other