MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Model Number 209063

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/05/2019

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

Surgeon complained that back trigger on mics that allows surgeon to pivot handle was broken and needed to be replaced.No adverse events to patient or user.Case type: tka.

Manufacturer Narrative

Surgeon complained that back trigger on mics that allows surgeon to pivot handle was broken and needed to be replaced.No adverse events to patient or user.Case type: tka product inspection: mics-209063, sn#: (b)(6), lot#42050318, rma#: (b)(4).Inspected per d06917 and determined failure of the following test step.Sec# 7.1.3.Failed pivot handle lock test.Pivot handle broke off.Disposition: rtv.Inspected by: steven henriquez.Device history review: device history records indicate (b)(4) devices were manufactured under lot k0b19 and all devices were accepted into final stock on 04/04/2018.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, lot number 42050318 shows 3 additional complaints related to the failure in this investigation.Conclusion: the alleged failure mode was confirmed.No additional investigation or specific actions are required.¿ if additional information is received then the complaint will be reopened.

Event Description

Surgeon complained that back trigger on mics that allows surgeon to pivot handle was broken and needed to be replaced.No adverse events to patient or user.Case type: tka.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9396703
• MDR Text Key: 188358316
• Report Number: 3005985723-2019-00870
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209063
• Device Catalogue Number: 209063
• Device Lot Number: 42050318 / 4203810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization