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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 Problems Mechanical Problem (1384); Mechanical Jam (2983)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2020
Event Type  Injury  
Event Description
It was reported that during a cori ukr procedure, after cutting about half of the femur, it was noticed that it was difficult to bur, in exposure mode bur was spinning slow and would not cut, in speed bur, it would not spin and when tried in off mode, it would also not spin. The bur and drill attachment were removed in bur change screen and recalibrated, but the issue was not solved. There was no drill attachment backup. The surgeon finished the rest of the cuts with a saw and checked with cori. This caused a delay of less than 30 minutes.
 
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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 Key10411817
MDR Text Key203092628
Report Number3010266064-2020-01713
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 01/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB10015
Device Catalogue NumberROB10015
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/15/2020 Patient Sequence Number: 1
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