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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 Unstable (1667); Connection Problem (2900)
Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2021
Event Type  Injury  
Event Description
It was reported that during a cori assisted tka surgery, the real intelligence robotic drill had a disconnect error. They proceeded to quit, unplugged, re-plugged and calibrate the same device and were able to continue. During this surgery, the bur had jumped and taken extra bone in the eminence ridge upon implantation and trialing. The surgeon put a 2-3mm gap stick in the joint space of the medial compartment. Upon forcing the leg into extension the tib bone fractured. They were unsure if this fracture was from the "extra bone" taken from the bur. They did end up explanting all implants and converting to a total. The procedure was completed, with a minimal delay (fewer than 30 minutes) using the same device. No patient injuries and no other complications were reported.
 
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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 Key11891117
MDR Text Key252901833
Report Number3010266064-2021-00421
Device Sequence Number1
Product Code OLO
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberROB10013
Device Catalogue NumberROB10013
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/18/2022
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: 05/26/2021 Patient Sequence Number: 1
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