MAUDE Adverse Event Report: MAKO SURGICAL CORP. HIP END EFFECTOR, VARIABLE ANGLE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 206967

Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)

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

Event Date 11/27/2018

Event Type  malfunction  

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 Description

Surgeon noticed metal ring moving back and forth inside window.When case was done metal ring came out of the window.Looks to be broken.Case type: tha.

Event Description

Surgeon noticed metal ring moving back and forth inside window.When case was done metal ring came out of the window.Looks to be broken.Case type: tha.

Manufacturer Narrative

Reported event: it was reported that surgeon noticed metal ring moving back and forth inside window.When case was done metal ring came out of the window.Looks to be broken.Product evaluation and results: as per attached picture the failure mode was confirmed as the provided picture shows that the metal ring broke off and came out from the device.Product history review: review of the product history records indicate 24 devices were manufactured under lot no 19040914 and accepted into final stock on 04/30/2015.Review of npr 15-04-004 revealed that the non-conformance is not related to the failure alleged in this compliant.

• Brand Name: HIP END EFFECTOR, VARIABLE ANGLE
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8173473
• MDR Text Key: 130631917
• Report Number: 3005985723-2018-00758
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486022167
• UDI-Public: 00848486022167
• Combination Product (y/n): N
• PMA/PMN Number: K121064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 206967
• Device Lot Number: 19040914
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization