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

Model Number 209999

Device Problems Difficult or Delayed Positioning (1157); Unintended Movement (3026)

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

Event Date 02/14/2020

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

Case number: (b)(4).Case description: (b)(4)- mps reported arm shaking/vibrating significantly in haptics.Case type : not reported.

Manufacturer Narrative

Reported event: it was reported that case number: (b)(4).Case description: (b)(6) - mps reported arm shaking/vibrating significantly in haptics.Product evaluation and results: as per work order: could not duplicate problem, spoke with mps and he had stated that he believed it was the saw attachment.Tested robot in accordance with service manual, kincalled right and left side.System investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Product history review: a review of device history records shows that (b)(6) was inspected and accepted into stock on 7/17/2015 and was handled via npr.A review of the data revealed that the non-conformances is not related to the failure alleged in this complaint.Complaint history review: a review of complaints in trackwise related to (b)(6) shows no additional complaints related to the failure in this investigation.Conclusions: the failure is not confirmed via inspection.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.

Event Description

Case number: (b)(4).Case description: (b)(6) - mps reported arm shaking/vibrating significantly in haptics.Case type : not reported.

• 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: 9821822
• MDR Text Key: 183114296
• Report Number: 3005985723-2020-00148
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• 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: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other