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

Model Number 209063

Device Problems Nonstandard Device (1420); 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

Stryker has initiated a voluntary, serial number specific recall for the mako integrated cutting system (mics) within scope of pfa. An updated communication will be forwarded upon completion of the internal investigation on this issue.

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.

• Brand Name: HANDPIECE MICS
• 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: 10779604
• MDR Text Key: 216366340
• Report Number: 3005985723-2020-00333
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• 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

• 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: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0472-2021

Patient Treatment Data

Date Received: 11/03/2020 Patient Sequence Number: 1