• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTIC DRILL GUARD ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10016
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2021
Event Type  Injury  
Event Description
It was reported that, during a cori assisted ukr surgery, while removing bone on femur in exposure control they experience noise from bur rubbing against inside of real intelligence robotic drill guard before noticing the suction barb detaching from side of guard and breaking off (case-(b)(4)). They switch out the guard and experienced the same friction. They examined the bur to make sure it was clear of debris and replaced the guard a third time. Again they noticed the friction against the inside of guard (case-(b)(4)and case-(b)(4)). They decided to continue bone removal in speed control mode to finish the case, and made it without further issues. The barb broke off only from one of the three guards however all guards experienced the friction. The procedure was finished, without significant delay, using a smith and nephew back up device. The patient was not harmed beyond the reported problem.
 
Manufacturer Narrative
Internal complaint reference case-(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREAL INTELLIGENCE ROBOTIC DRILL GUARD
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 Key13087633
MDR Text Key282774178
Report Number3010266064-2021-00903
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberROB10016
Device Catalogue NumberROB10016
Device Lot Number1341425
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2022
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

Patient Treatment Data
Date Received: 12/27/2021 Patient Sequence Number: 1
-
-