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U.S. Department of Health and Human Services

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

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MAKO SURGICAL CORP. HANDPIECE MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 209063
Device Problem Failure to Calibrate (2440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2020
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. 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
Angled blade will not pass on robot. If you physically move the blade to one end of the "sweep" it says it's off by 5 or 6mm. If you move it to the other end it passes. Tried multiple attachments, and mics and it still did this. Even got attachments from another facility to test. Case type / application: tka.
 
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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 Key10754499
MDR Text Key213636066
Report Number3005985723-2020-00325
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,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number209063
Device Catalogue Number209063
Device Lot Number42070420
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 Received12/02/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0472-2021

Patient Treatment Data
Date Received: 10/29/2020 Patient Sequence Number: 1
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