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

Model Number 219999

Device Problems Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Laceration(s) (1946); Hip Fracture (2349)

Event Date 10/26/2021

Event Type  Injury  

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 robot issues.Mps reported reaming through medial wall and other issues.As reported via complaint form: after impaction, 48 cup would not stick.Surgeon indicated that posterior wall may have been reamed through.Surgical delay = 15 minutes.Case completed manually.Case type / application: tha 4.0.Update: additional information received from mps: "the surgeon indicated that she did not notice the posterior medial wall having damage until after cup impaction.Another surgeon who helped her with the repair/augment stated that he believed it may have been caused during cup impaction in combination with a thin medial wall as opposed to the reaming portion.".

Event Description

Mps reported robot issues.Mps reported reaming through medial wall and other issues.As reported via complaint form: after impaction, 48 cup would not stick.Surgeon indicated that posterior wall may have been reamed through.Surgical delay = 15 minutes.Case completed manually.Case type / application: tha 4.0.Update: additional information received from mps: "the surgeon indicated that she did not notice the posterior medial wall having damage until after cup impaction.Another surgeon who helped her with the repair/augment stated that he believed it may have been caused during cup impaction in combination with a thin medial wall as opposed to the reaming portion.".

Manufacturer Narrative

Reported event: an event regarding inaccurate reaming involving a mako tha software was reported.The event was confirmed.Method & results: -product evaluation and results: review of the case session files noted the following: from the registration performed it seems like few points were picked on the fovea instead of picking them all on the articular surface as per design as seen in the log review which contributed to the error in registration.The crest point was not probed on the surface of the bone which also contributed to the error in registration.After the collection of verification regions(one region failed) and prior to moving to the reaming page, the application provided the low confidence in registration accuracy message requesting the user to re-register as seen below in summary, it seems like the registration executed here was of low confidence accuracy due to the above stated points and the application provided the feedback to the user to re-register/reverify.In addition, the plan was very close to medial wall(~2mm) which is our system accuracy specification for tha, suggestion would be to lateralize the plan in the future.The field service engineer reported: problem reproduced? no.Trouble shooting notes: none.Work performed: could not reproduce problem.Full pm completed.Successfully completed mako system pm per service manual.Verified all operations and calibrations.Cleaned fiber optics and camera.Adjusted/calibrated various joints including j3, j4, j5 and j6 for better accuracy/operation.Optimized j2 bump stop positioning.Successfully completed full kinematic calibration on both left and right sides and verified via auto arm accuracy.Successfully completed all tests and checks per service manual.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 rob1351 was inspected and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints shows 0 similar complaints 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: 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12853773
• MDR Text Key: 284967155
• Report Number: 3005985723-2021-00196
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2020
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female