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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); Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: (b)(4). The sample is under evaluation by manufacturing site.
 
Event Description
It was reported that, during set up for a cori-assisted surgery, the real intelligence robotic drill did not passed the diagnostics three times. According to the picture attached, it failed the maximum stop time. The procedure was finished with a smith and nephew back up device without delays. The patient was not harmed as a consequence of this issue. Moreover, while testing the real intelligence robotic drill during investigation,it had an exposure motor failure.
 
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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 Key14004085
MDR Text Key288588821
Report Number3010266064-2022-00244
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
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB10013
Device Catalogue NumberROB10013
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2022
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: 04/04/2022 Patient Sequence Number: 1
Treatment
CORI ROBOTICS USA-(B)(4)
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