MAUDE Adverse Event Report: MAKO SURGICAL CORP. PLATE, CAMERA MOUNT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209999

Device Problems Loss of Power (1475); Intermittent Communication Failure (4038)

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

Event Date 07/19/2021

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

Case number: (b)(4): mps reported camera connection issues.While trying to make posterior cuts, arm was aligning to anterior cuts.Mps checked arrays, camera cleanliness, and no yellow fault light is visible.Arm status was then giving cutter error.Mps shutdown, ran double bypass, and error/issue resolved.Surgery was completed robotically.

Manufacturer Narrative

Additional manufacturer narrative: reported event: an event regarding locking mechanism failure involving a mako camera stand was reported.The event was confirmed.Method & results: product evaluation and results: the field service engineer reported: problem reproduced? yes.Work performed: found camera mount loose, tightened camera mount, cleaned all fibers and ran all applicable testing.Placed robot back into service.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 the device history records cannot be conducted as the lot/serial number was not reported.Complaint history review: a complaint history review cannot be conducted as the lot/serial number was not reported.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.H3 other text: device not returned.

Event Description

Case number: (b)(4): mps reported camera connection issues.While trying to make posterior cuts, arm was aligning to anterior cuts.Mps checked arrays, camera cleanliness, and no yellow fault light is visible.Arm status was then giving cutter error.Mps shutdown, ran double bypass, and error/issue resolved.Surgery was completed robotically.

• Brand Name: PLATE, CAMERA MOUNT
• 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: 12318432
• MDR Text Key: 266408588
• Report Number: 3005985723-2021-00138
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• 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: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• 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: 204696
• Device Lot Number: ROB610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: No
• 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