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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI BONE PINS 4 MM X 152 MM QTY: 2; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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BLUE BELT TECHNOLOGIES RI BONE PINS 4 MM X 152 MM QTY: 2; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10011
Medical Device Problem Codes Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/28/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that, during a cori-assisted surgery, the bur contacted the ri bone pin 4 mm x 152 mm, therefore, the pin was damaged (damaged threads).There was no delay and no patient was harmed.It is unknown how the procedure was finished.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand Name
RI BONE PINS 4 MM X 152 MM QTY: 2
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
MDR Report Key11823004
Report Number3010266064-2021-00383
Device Sequence Number11822808
Product Code OLO
UDI-Device Identifier00885556757307
UDI-Public00885556757307
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K193120
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberROB10011
Device Catalogue NumberROB10011
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/28/2021
Supplement Date Received by Manufacturer09/23/2021
Initial Report FDA Received Date05/13/2021
Supplement Report FDA Received Date09/25/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
REAL INTELLIGENCE CORI; REAL INTELLIGENCE CORI
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