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

Catalog Number 209063

Device Problems Output Problem (3005); Intermittent Loss of Power (4016)

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

Event Date 09/30/2019

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.Additional info was added october 15th that made this reportable.

Event Description

Mics failed in the middle of a cut and failed mics status check after the case.Surgery completed manually.Case type: tka.Update: as per response, "there was one replacement mics which also failed and the case was completed manually.The handpiece has already been returned and replaced.".

Manufacturer Narrative

Mics failed in the middle of a cut and failed mics status check after the case.Surgery completed manually.Product evaluation and results: mics-209063, sn# (b)(6), lot#42050816, rma# (b)(4).Inspected per d06917 and determined failure of the following test step.Sec# 7.1.2: failed visual inspection.Disposition: rtv.Inspected by: (b)(6).Product history review: device history records indicate (b)(4) were manufactured under lot k08cd and (b)(4) were accepted into final stock on 09/21/2016.A review of qt16-09-0075 revealed that the issue is not related to the failure alleged in this compliant.Complaint history review: a review of complaints related to parts in lot number k08cd, p/n 209063 shows 03 other complaints related to the failure in this investigation.Conclusions: the alleged failure mode was confirmed.No additional investigation or specific actions are required.

Event Description

Mics failed in the middle of a cut and failed mics status check after the case.Surgery completed manually.Case type: tka.Update: as per response, "there was one replacement mics which also failed and the case was completed manually.The handpiece has already been returned and replaced.".

• 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: 9297373
• MDR Text Key: 180410616
• Report Number: 3005985723-2019-00796
• 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: 12/09/2019

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 Catalogue Number: 209063
• Device Lot Number: 42050816/4201086
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 11/11/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization