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

Model Number 219999

Device Problem Unintended Movement (3026)

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

Event Date 10/18/2022

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

Mps says the robot will get into haptics and start to oscillate so much it kicks itself out of haptics.

Manufacturer Narrative

Reported event an event regarding unintended movement involving a mako robotic arm was reported.The event was not confirmed.Method & results: product evaluation and results: the field service engineer reported: problem reproduced? no.Trouble shooting notes: robot ¿ mps says the robot will get into haptics and start to oscillate so much it kicks itself out of haptics.Work performed: adjusted j5, j6, j4.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: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there are no other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was not confirmed.Successfully completed all checks, verifications, and calibrations.System is ready for clinical use.

Event Description

Mps says the robot will get into haptics and start to oscillate so much it kicks itself out of haptics.

• Brand Name: MAKO ROBOTIC ARM 3.1
• 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: perla zima ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 15776243
• MDR Text Key: 304888668
• Report Number: 3005985723-2022-00147
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142530
• 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: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 219999
• Device Catalogue Number: 219999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2020
• 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