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

Model Number 209063

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 11/08/2019

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

Handle fell off during use.Case type: tka.

Event Description

Handle fell off during use.Case type: tka.

Manufacturer Narrative

Reported issue: handle fell off during use.Case type: tka.Product inspection: visual inspection.Mics-209063 sn#(b)(6); rma#(b)(4).Inspected per d06917 and determined failure of the following test step.Sec# 7.1.2.Visual missing handle.Disposition: rtv.Inspected by: (b)(6).Device history review: review of device history record indicate that (b)(4) devices were manufactured under lot 42020319 and (b)(4) accepted and (b)(4) rejected on 04/04/2019.Review of (b)(4) revealed that the non conformance is not related to the failure alleged in this complaint.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, lot number42020319 shows no 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.Nc/capa review: a review of stryker¿s nc/capa database indicated there have been an nc and capa associated with the product and failure mode reported in this event.This is (b)(4) and capa 1452931.

• 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: 9396722
• MDR Text Key: 177393853
• Report Number: 3005985723-2019-00877
• 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: 02/14/2020

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: 42020319 / 4206184
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization