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

Model Number 209999

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 02/20/2020

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 (b)(6) reported arm shaking in haptics.Case type : tka.Update per response: surgical delay <15 min.

Manufacturer Narrative

Reported event: it was reported that case number: (b)(4).Case description: (b)(6) - mps reported arm shaking in haptics.Case type : tka.Update per response: surgical delay <15 min.Product evaluation and results: as per work order, i performed a complete check of testing on the arm.All testing, verification and calibration passed.No errors during testing.System is ready for clinical use.Product history review: a review of device history records shows that (b)(6) was inspected and accepted into stock on 08/03/2017 and was handled via qt.A review of the data revealed that the non-conformance's 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

(b)(4).Case description: (b)(6) - mps reported arm shaking in haptics.Case type : tka.Update per response: surgical delay <15 min.

• 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: 9837795
• MDR Text Key: 183784144
• Report Number: 3005985723-2020-00162
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• 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: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other