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

Model Number 209999

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2022

Event Type  malfunction  

Event Description

During reaming arm was pushing the surgeon/reamer far anterior.Not matching the planned ream.All physicals were checked and checkpoints passed multiple times.Case type / application: tha.

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.

Manufacturer Narrative

Reported event.An event regarding unintended movement involving a mako robotic arm was reported.The event was not confirmed because the product was not available for inspection.Method & results.-product evaluation and results: the alleged failure mode was not confirmed as there has been no onsite inspection by a field service engineer.If a field service inspection is requested, further investigation will be completed on this issue.Additionally, a complaint history review provides no indication of any inherent software/ hardware issue.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that (b)(6) was inspected and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints in trackwise robot number: (b)(6) shows no other complaints related to the failure in this investigation.Conclusions: the alleged failure mode was not confirmed as there has been no onsite inspection by a field service engineer.If a field service inspection is requested, further investigation will be completed on this issue.Additionally, a complaint history review provides no indication of any inherent software/ hardware issue.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.

Event Description

During reaming arm was pushing the surgeon/reamer far anterior.Not matching the planned ream.All physicals were checked and checkpoints passed multiple times.Case type / application: tha.

• 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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: kelsey williams ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15301259
• MDR Text Key: 300447348
• Report Number: 3005985723-2022-00114
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other