MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209063

Device Problems Failure to Calibrate (2440); Complete Loss of Power (4015)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Serial specific voluntary recall was initiated for the mako integrated cutting system (mics) within scope of a capa.The initial root cause analysis determined that the process for characterizing mics handpieces for specific serial numbers deviated from its qualified state at the time of validation.The capa investigation is currently in progress and an updated communication will be submitted upon completion of the investigation.

Event Description

Surgical team had just successfully completed all cuts with the straight sawblade.When trying to pass the angled sawblade checkpoint, system would consistently throw an error of 4-4.5mm.We confirmed end effector assembly, swapped out all instrumentation (base array, angled sawblade attachment, sawblade, rio registration tool, end effector array, mics handpiece, vizadiscs), re-did 'rio registration', moved the robot to a different location, cleaned camera lens, did a full restart and re-homed.Error still held consistently at 4-4.5mm.I instructed surgeon to use the e-stop and support the underside of the sawblade with his finger and the error was the same.

Event Description

Surgical team had just successfully completed all cuts with the straight sawblade.When trying to pass the angled sawblade checkpoint, system would consistently throw an error of 4-4.5mm.We confirmed end effector assembly, swapped out all instrumentation (base array, angled sawblade attachment, sawblade, rio registration tool, end effector array, mics handpiece, vizadiscs), re-did 'rio registration', moved the robot to a different location, cleaned camera lens, did a full restart and re-homed.Error still held consistently at 4-4.5mm.I instructed surgeon to use the e-stop and support the underside of the sawblade with his finger and the error was the same.

Manufacturer Narrative

Reported issue surgical team had just successfully completed all cuts with the straight sawblade.When trying to pass the angled sawblade checkpoint, system would consistently throw an error of 4-4.5mm.We confirmed end effector assembly, swapped out all instrumentation (base array, angled sawblade attachment, sawblade, rio registration tool, end effector array, mics handpiece, vizadiscs), re-did 'rio registration', moved the robot to a different location, cleaned camera lens, did a full restart and re-homed.Error still held consistently at 4-4.5mm.I instructed surgeon to use the e-stop and support the underside of the sawblade with his finger and the error was the same.Product inspection the failure is confirmed as it is under the scope of nc: mics characterization process deviated from the qualified state.Also the serial number ¿4209494¿ lies in the urgent medical device recall list and hence archived.Device history review review of the device history records indicate 25 devices were manufactured under lot id 42100520, and 25 were accepted into final stock on 06/04/2020.No non-conformances were identified during inspection.Complaint history review a review of complaints in trackwise related to p/n 209063, lot number 42100520 shows 6 additional complaints related to the failure in this investigation.Conclusion mics headpiece- serial number specific recall was initiated for the mics handpieces within scope of a capa.The investigation revealed that only specific the catalog number and serial numbers are impacted by the regulatory action.The root cause analysis identified a characterization issue associated with the mako integrated cutting system (mics) handpiece.Users have been instructed to return any specified hand piece to stryker.

• Brand Name: HANDPIECE MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10785528
• MDR Text Key: 216405777
• Report Number: 3005985723-2020-00342
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209063
• Device Catalogue Number: 209063
• Device Lot Number: 42100520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0472-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other