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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); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2021
Event Type  malfunction  
Manufacturer Narrative
Reference number: case- (b)(4).
 
Event Description
It was reported that, during a cori assisted tka surgery, they experienced drill time outs while attempting to complete the distal medial femur bone prep. They would immediately receive the time out notice upon contacting distal femur. After three unsuccessful attempts at selecting "continue", they chose to exit the case, disconnect the real intelligence robotic drill from the console, reconnect the same drill, and recalibrate the drill. After this step, the drill continued to produce a time-out message as the physician contacted the distal femur with the robotic drill. The procedure was finished with a smith and nephew back up device with a significant delay. The patient was not harmed beyond the reported problem. Then, when they tested the drill, the drill failed the drill diagnostic test twice. The drill specifically failed "random exposure, set maximum speed, and maximum retraction time", but passed: maximum stop time and minimum homing torque".
 
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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 Key12788357
MDR Text Key280597111
Report Number3010266064-2021-00755
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556757321
UDI-Public00885556757321
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
Reporter Occupation
Type of Report Initial
Report Date 11/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2021
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? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/21/2021
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 Reuse

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