MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 219999

Device Problems Positioning Failure (1158); Failure to Calibrate (2440)

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

Event Date 10/31/2023

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.H3 other text : device not returned.

Event Description

Mps says that j5 isn¿t working correctly and isn't aligning to cuts and the arm would lock up in homing.Mps also says that j5 would make a crunching with a noise pushed too hard error and is not aligning to the correct plane.

Event Description

Mps says that j5 isn¿t working correctly and isn't aligning to cuts and the arm would lock up in homing.Mps also says that j5 would make a crunching with a noise pushed too hard error and is not aligning to the correct plane.

Manufacturer Narrative

An event regarding registration fails involving a mako robotic arm was reported.The event was confirmed.Method & results: -product evaluation and results: the field service engineer reported: problem reproduced: yes troubleshooting notes: none work performed: reported problem ¿ difficulty rotating j5.Observation ¿ aged j5 bump stop was not sliding on the rail appropriately.Action taken ¿ replaced j5 bump stop carriage and rail.System ready for clinical use.Work order disposition: system investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that was inspected on and the quality inspection procedures were completed with no reported discrepancies -complaint history review: there have been other complaints with similar event(s) for the lot referenced.Conclusions: the alleged failure mode was confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text : device not returned to the manufacturer.

• Brand Name: MAKO ROBOTIC ARM 3.1
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18195229
• MDR Text Key: 328831713
• Report Number: 3005985723-2023-00175
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 219999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2020
• 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