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

Catalog Number 209063

Device Problems Connection Problem (2900); Output Problem (3005)

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

Event Date 10/23/2019

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

When entering bone prep the mics failed to communicate with the robot causing the green to not disappear when cutting.Case type: tka.Surgical delay: > 30 minutes.

Event Description

When entering bone prep the mics failed to communicate with the robot causing the green to not disappear when cutting.Case type: tka.Surgical delay: > 30 minutes.

Manufacturer Narrative

It was reported that when entering bone prep the mics failed to communicate with the robot causing the green to not disappear when cutting.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Capa has been raised for lost product.If the device is returned then the complaint will be reopened.Product history review device history records indicate 25 devices were manufactured under lot kocov and 25 were accepted into final stock on 11-27-2018.No non-conformances were identified during inspection.Complaint history review a review of complaints related to p/n 209063, prodex lot kocov shows no additional complaint(s) related to the failure in this investigation.Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• 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: 9258407
• MDR Text Key: 177247305
• Report Number: 3005985723-2019-00769
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• 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: 4205230
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization