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

Catalog Number 209063

Device Problems Loss of Power (1475); Output Problem (3005)

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

During the case as we went to go ream we didn't have any power even though the robot said we should so we switched out the mics and tried again and still didn't have power.We shut down the robot and still no power so we reamed manually.Clinical support was called when the mics status check failed.We took the robot out of the room and shut it down and tried a new mics and it passed mics status check so we concluded it was the two mics that were bad surgical delay 16-30 minutes.Case type: tha.

Manufacturer Narrative

Reported event: it was reported that during the case as we went to go ream we didnt have any power even though the robot said we should so we switched out the mics and tried again and still didnt have power.We shut down the robot and still no power so we reamed manually.Clinical support was called when the mics status check failed.We took the robot out of the room and shut it down and tried a new mics and it passed mics status check so we concluded it was the two mics that were bad surgical delay-16-30 minutes.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Product history review: device history records indicate 25 devices were manufactured under prodex lot k0b9z and all 25 devices were accepted into final stock on 05/30/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, lot k0b9z shows 03 additional complaint(s) related to the failure in this investigation.The related complaint is (b)(4).Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.Corrective action/preventive action: 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 nc1414517 and capa 1450904.Product was not available for evaluation.

Event Description

During the case as we went to go ream we didnt have any power even though the robot said we should so we switched out the mics and tried again and still didnt have power.We shut down the robot and still no power so we reamed manually.Clinical support was called when the mics status check failed.We took the robot out of the room and shut it down and tried a new mics and it passed mics status check so we concluded it was the two mics that were bad surgical delay-16-30 minutes.Case type: tha.

• 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: 8177264
• MDR Text Key: 130786871
• Report Number: 3005985723-2018-00765
• 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: 03/25/2019

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: 209063
• Device Lot Number: 42040518/4204083
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization