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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HANDPIECE MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT

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STRYKER ORTHOPAEDICS-MAHWAH HANDPIECE MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
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Brand NameHANDPIECE MICS
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
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 Key10785408
MDR Text Key216414890
Report Number3005985723-2020-00338
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486030193
UDI-Public00848486030193
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 Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number209063
Device Catalogue Number209063
Device Lot Number42100520
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2020
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: 11/04/2020 Patient Sequence Number: 1
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