• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAKO SURGICAL CORP. HANDPIECE MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHANDPIECE MICS
Type of DeviceORTHOPEDIC 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 Key10779645
MDR Text Key216338998
Report Number3005985723-2020-00335
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142530
Number of Events Reported1
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 Received11/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number209063
Device Catalogue Number209063
Device Lot Number42030520
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2020
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 NumberZ-0472-2021

Patient Treatment Data
Date Received: 11/03/2020 Patient Sequence Number: 1
-
-