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

Model Number 219999

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/14/2022

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 manager reported inaccurate cuts.Ongoing issue with distal femur cut being deep by 0.5-1.5mm despite no red showing during 'bone prep' and planar probe readings showing accurate cuts being made.

Event Description

Mps manager reported inaccurate cuts.Ongoing issue with distal femur cut being deep by 0.5-1.5mm despite no red showing during 'bone prep' and planar probe readings showing accurate cuts being made.

Manufacturer Narrative

Reported event an event regarding inaccurate resection 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: angled cut are 1.5mm off consistent.Both right and left sides affected.Multiple instruments/mics have been replaced with no change in symptom.Multiple fse have visited for this problem and according to the mps the cuts have consistently been 1.5mm deep work performed: clean cables / connect system / presurg with no issue.System has older version of software so we installed newer version in case there may be a glitch in ss2u.J2 bump stops were set to manufacturer spec.Open j6 and clean debris from read head glass, ran homing and then kincal to calibrate the arm.All checks performed passed successfully and the system is functioning to manufacturer specs.It 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 the robot was inspected and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints shows other complaints related to the failure in this investigation.Conclusions: the alleged failure mode was not reproduced through an onsite inspection carried out by a field service engineer however the system was optimized for clinical use and an updated version of the software was installed.Additionally, a complaint history review provides no indication of any inherent software/ hardware issue.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: 15552403
• MDR Text Key: 301363978
• Report Number: 3005985723-2022-00127
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07613327395280
• UDI-Public: 07613327395280
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 11/17/2022
• Supplement Dates FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2020
• 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