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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10015
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2021
Event Type  Injury  
Event Description
It was reported that, during a cori-assisted tka surgery, the swap bur button icon was pressed by accident as it is right next to the planning button. The case was sent back to the bur selection screen and the recalibrate step for the real intelligence robotic drill was necessary, then a calibration error message was displayed and was solved through troubleshooting. The case was exit and re-entered. Upon unlocking the drill a drill disconnect error message was displayed. The drill attachment was checked to see if it was fully looked and the case was exit, the drill was unplugged and plugged back in, the drill attachment was locked and the case was re-entered. A second drill disconnect error message was displayed when unlocking the drill for bur loading. After troubleshooting another drill disconnect error was displayed at the unlock screen (case-(b)(4)). It is unknown if this issue was caused by the real intelligence cori (case-(b)(4)). The drill was swapped, but the long attachment, tracker frame or the exposure guard were not swapped. At this point, the surgeon decided to finish the case with manual instrumentation. No significant delays (fewer than 30 minutes) were reported and the patient was not harmed. Additionally, after the case, the real intelligence robotic drill was assembled and when pressing unlock to load the burr, it was felt that the drill attachment rotated as if the unlocking mechanism of the drill caused the long attachment to rotate (case-(b)(4)). It is unknown if the drill attachment also contributed to this issue (case-(b)(4)).
 
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Brand NameRI ROBOTIC DRILL ATTACHMENT
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 Key11858355
MDR Text Key260546396
Report Number3010266064-2021-00395
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 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 Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberROB10015
Device Catalogue NumberROB10015
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/06/2022
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: 05/20/2021 Patient Sequence Number: 1
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