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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTIC DRILL ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTIC DRILL ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10013
Device Problems Failure to Calibrate (2440); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2022
Event Type  Injury  
Event Description
It was reported that, during set up for a cori assisted tka surgery, they ran a diagnostic test on the real intelligence robotic drill and it failed. A message popped up that said the robotic drill has an internal error. The real intelligence robotic drill tracker and the ri robotic drill attachment are locked on the drill. The procedure was completed with manual instrumentation without delay. The patient was not harmed.
 
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
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Brand NameREAL INTELLIGENCE ROBOTIC DRILL
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key13698229
MDR Text Key286926209
Report Number3010266064-2022-00177
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB10013
Device Catalogue NumberROB10013
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/08/2022 Patient Sequence Number: 1
Treatment
CORI ROBOTICS USA-(B)(4); REAL INTELLIGENCE ROBOTIC DRILL TRACKER-ROB10014
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