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

Model Number 210080

Device Problems Degraded (1153); Material Integrity Problem (2978)

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

Event Date 09/19/2019

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

The carbon fiber portion of the leg holder is starting to chip and stick out and is very sharp.Case type: tka.

Manufacturer Narrative

The carbon fiber portion of the leg holder is starting to chip and stick out and is very sharp.Case type: tka product evaluation and results: visual inspection as per the image provided showed splintering in the carbon fiber.Also product was unavailable for inspection capa (b)(4) has been raised for the same.Product history review: a) review of the device history records for lot 201743060801 indicate 32 devices were manufactured and accepted into final stock on 06-14-2017 with no reported discrepancies.B) review of the device history records for lot 201843012201 indicate 1.19 devices were manufactured and accepted into final stock on 01-23-2018 with no reported discrepancies.2.7 devices were manufactured and accepted into final stock on 01-24-2018 with no reported discrepancies.3.124 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 201743060801 shows 2 additional complaints related to the failure in this investigation.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.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.

Event Description

The carbon fiber portion of the leg holder is starting to chip and stick out and is very sharp.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: 9119791
• MDR Text Key: 160156485
• Report Number: 3005985723-2019-00697
• 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: 01/27/2020

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 / 20174306080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 12/30/2019
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization