MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209999

Device Problems Failure to Calibrate (2440); Output Problem (3005)

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.

Event Description

Mics failed intra-op and then failed mics status check post-op.Case type: tka.Surgical delay: 30 minutes related pi (b)(4).Update: "we had one replacement and it also failed.We had to complete our final recut manually.".

Manufacturer Narrative

Update to b2 and d2.Reported event: it was reported that mics failed intra-op and then failed mics status check post-op.Case type: tka surgical delay: 30 minutes update: "we had one replacement and it also failed.We had to complete our final recut manually." product evaluation and results: mics-209063 sn# (b)(6) lot#42060618 product history review: device history records indicate 25 devices were manufactured and all 25 devices were accepted into final stock on 07/13/2018.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, lot 42060618 shows 7 additional complaints related to the failure in this investigation.Conclusions: the failure is confirmed via inspection.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.

Event Description

Mics failed intra-op and then failed mics status check post-op.Case type: tka surgical delay: 30 minutes.Related pi 2202453.Update: "we had one replacement and it also failed.We had to complete our final recut manually.".

• Brand Name: 3.0 RIO ROBOTIC ARM - MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9165870
• MDR Text Key: 175449411
• Report Number: 3005985723-2019-00723
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other