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

Model Number 219999

Device Problems Positioning Failure (1158); Incorrect, Inadequate or Imprecise Result or Readings (1535); Positioning Problem (3009)

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

Event Date 10/02/2021

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

Bilateral mako tha procedure (da approach), right side completed first without issue.Switched off and moved robot to left side side to prep for left side of bilateral hip, rebooted and found both mako monitors displaying a screen with blinking square progress bar (i recorded video of it to upload).This screen could not be altered with soft reboot.Completed hard reboot and same screen reappeared.Waited several minutes before login screen appeared and proceeded to re-home robot.I didn¿t think much of this startup issue until an issue developed when surgeon began reaming acetabulum.Surgeon reamed medial to plan with the mako causing a protrusio.Everything checked out okay (registration passed fine, both checkpoints passed, offset reamer orientation 90-deg matching robot, reamer size basket etc).Preplan was medialised from native centre of rotation but obviously not through medial wall.Surgeon fixed situation with bone graft impaction to plug it using reverse ream and we used mako to impact cup (proud 6mm which clinically was seated well and would suggest the measurement of cup impaction to plan based off the deepest over-ream was accurate.Final reduction numbers were clinically matching preplan.Have downloaded session log files for pi and exported reidentified mako case plan for upload.My only thoughts were if pelvic array was toggled/leaned on during the reaming.Our haptics lock into planned centre of cup rotation preventing reidentified.This cor must have changed (by array movement?).The fact that robot and patient registrations passed + verified, and checkpoints passed to begin reaming, then the only other variable would be movement of array.If pelvic array was toggled or leaned on during reaming, it could shift plan.Otherwise robot is constrained to reaming a perfect hemisphere.The fact that we never saw ¿red¿ when we ended up being deeper could also suggest discrepancy between robot plan and actual patient occurring during the reaming process.The fact that the cup impaction and reduction numbers appeared accurate could also suggest something may have happened to the array only during the reaming step.Finally, and to the initial point about the rebooted mako screen issue that immediately preceded this reaming issue, i wish to rule out any system issue that could have caused surgeon to over ream.Bilateral mako hip, right side completed first without issue.Left side mako power-down then reboot followed by left-sided over-reaming issue are reason for this pi.

Manufacturer Narrative

Reported event: an event regarding inaccurate reaming involving a mako tha software was reported.The event was not confirmed.Method & results: -product evaluation and results: review of the case session files was not performed as case session data was not located.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that the product 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 exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session/log data are needed to complete the investigation for determining root cause.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

Bilateral mako tha procedure (da approach), right side completed first without issue.Switched off and moved robot to left side side to prep for left side of bilateral hip, rebooted and found both mako monitors displaying a screen with blinking square progress bar (i recorded video of it to upload).This screen could not be altered with soft reboot.Completed hard reboot and same screen reappeared.Waited several minutes before login screen appeared and proceeded to re-home robot.I didn¿t think much of this startup issue until an issue developed when surgeon began reaming acetabulum.Surgeon reamed medial to plan with the mako causing a protrusio.Everything checked out okay (registration passed fine, both checkpoints passed, offset reamer orientation 90-deg matching robot, reamer size basket etc).Preplan was medialised from native centre of rotation but obviously not through medial wall.Surgeon fixed situation with bone graft impaction to plug it using reverse ream and we used mako to impact cup (proud 6mm which clinically was seated well and would suggest the measurement of cup impaction to plan based off the deepest over-ream was accurate.Final reduction numbers were clinically matching preplan.Have downloaded session log files for pi and exported deidentified mako case plan for upload.My only thoughts were if pelvic array was toggled/leaned on during the reaming.Our haptics lock into planned centre of cup rotation preventing overreaming.This cor must have changed (by array movement?).The fact that robot and patient registrations passed + verified, and checkpoints passed to begin reaming, then the only other variable would be movement of array.If pelvic array was toggled or leaned on during reaming, it could shift plan.Otherwise robot is constrained to reaming a perfect hemisphere.The fact that we never saw ¿red¿ when we ended up being deeper could also suggest discrepancy between robot plan and actual patient occurring during the reaming process.The fact that the cup impaction and reduction numbers appeared accurate could also suggest something may have happened to the array only during the reaming step.Finally, and to the initial point about the rebooted mako screen issue that immediately preceded this reaming issue, i wish to rule out any system issue that could have caused surgeon to over ream.Bilateral mako hip, right side completed first without issue.Left side mako power-down then reboot followed by left-sided over-reaming issue are reason for this pi.

• 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: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 12705410
• MDR Text Key: 278761993
• Report Number: 3005985723-2021-00175
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2021
• 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): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female