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

Mics handle screws fell out during surgery.Did not affect mics operation.Case type: tka.Update: "no debris/components left in patient.Single screw from hand piece fell out onto floor.Upon inspection, other similar screw was already missing.Pt scanned to ensure nothing inside.".

Manufacturer Narrative

Reported issue: mics handle screws fell out during surgery.Did not affect mics operation.Case type: tka.Update: ""no debris/components left in patient.Single screw from hand piece fell out onto floor.Upon inspection, other similar screw was already missing.Pt scanned to ensure nothing inside"".Product inspection: visual inspection: mics-209063, sn# (b)(6), rma# (b)(4), lot 42020516.Inspected per d06917 and determined failure of the following test step.Sec# 7.1.2.Visual missing screws.The mics had missing screws on the bottom side.Disposition: rtv inspected by: (b)(6).Dimensional inspection: dimensional inspection was not conducted since defect was confirmed in visual inspection.Functional inspection: functional inspection was not conducted since defect was confirmed in visual inspection.Device history review: device history records indicate 25 devices were manufactured under lot k07ml and all 25 devices were accepted into final stock on 7/5/2016.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, lot number 42020516 shows 2 additional complaints related to the failure in this investigation.The complaints are (b)(4).Conclusion: the alleged failure mode was confirmed by visual inspection.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 nc 1429704 and capa 1452931.

Event Description

Mics handle screws fell out during surgery.Did not affect mics operation.Case type: tka.Update: "no debris/components left in patient.Single screw from hand piece fell out onto floor.Upon inspection, other similar screw was already missing.Pt scanned to ensure nothing inside".

• 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: 9396761
• MDR Text Key: 177390770
• Report Number: 3005985723-2019-00874
• 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: 42020516 / 4200717
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 87 YR