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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 Overheating of Device (1437); Noise, Audible (3273); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2021
Event Type  malfunction  
Event Description
It was reported that, during a cori assisted tka lab/demo, an unusual sound was identified during drill test and also during sawbones trial. Eventually, after few tests attempt robotic drill stacked, gave unusual sound and stop spinning. There was no patient involvement. No other complications were reported. Upon investigation, it was found that the motor was hotter than expected.
 
Manufacturer Narrative
The real intelligence robotic drill intended to be used for treatment, was returned for evaluation. A relationship between the reported event and the device was established. The reported problem could not be visually confirmed. A functional evaluation was performed.   the reported problem was confirmed. On the 1st attempt: drill disconnect at diagnostics test. A case was attempted and a flashing checkmark/x failure was observed. On the second attempt, a loud drill squeak was heard during the diagnostic test. The drill failed minimum homing, and failed all tests on the third attempt. The motor was also found to be hotter than expected. A supplemental report will be sent with the completed results of investigation. Internal complaint reference number: (b)(4).
 
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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 Key13077237
MDR Text Key282719919
Report Number3010266064-2021-00898
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K201022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received01/14/2022
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 Reuse

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