• 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 12/01/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference case (b)(4).
 
Event Description
It was reported that during a cori assisted tka surgery, while burring two real intelligence robotic drill guards broke at the part of suction tube attachment. The procedure was completed, without delay, using a s+n back-up device. Patient was not harmed beyond the reported issue.
 
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 Key13054743
MDR Text Key282623602
Report Number3010266064-2021-00891
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K193120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB10016
Device Catalogue NumberROB10016
Device Lot Number1107083
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received03/08/2022
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

-
-