MAUDE Adverse Event Report: MAKO SURGICAL CORP. F17 COMPUTER ASSEMBLY, 3.X; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 219999

Device Problem Application Program Problem: Parameter Calculation Error (1449)

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

Event Date 12/29/2021

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 reported new system is lagging, green not going away in cuts, and unable to export session files.Case completed robotically.Update: no noticeable surgical delay.Less that minute.Tka.

Event Description

Mps reported new system is lagging, green not going away in cuts, and unable to export session files.Case completed robotically.Update: no noticeable surgical delay.Less that minute.Tka.

Manufacturer Narrative

Reported event: an event regarding computer failure 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.Trouble shooting notes: none.Work performed: replaced f17 computer while retaining original hard drive due to issues with pulling logs.All required testing was done.Found no more issues with robot.Robot is 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 (b)(6) was inspected and the quality inspection procedures were completed with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the alleged failure mode was confirmed.Successfully completed all checks, verifications, and calibrations.System is ready for clinical use.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

• Brand Name: F17 COMPUTER ASSEMBLY, 3.X
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, FL WD6 3-SJ ; UK WD6 3SJ ; 9546280700
• MDR Report Key: 13287917
• MDR Text Key: 285041901
• Report Number: 3005985723-2022-00009
• Device Sequence Number: 1
• Product Code: OLO
• 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: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• 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: 214820
• Device Lot Number: 504278-08348302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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