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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CHECKPOINT PINS QTY:4; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CHECKPOINT PINS QTY:4; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10012
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/26/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Our reference number: (b)(4).
 
Event or Problem Description
It was reported that after the cori tka procedure (where no errors or issues occurred), the checkpoint pins were not removed prior to closing the incision.The pins were detected on the post-op images while the patient was still in recovery.The patient was returned to the operating room, in which both checkpoint pins were successfully removed via two skin incisions and c-arm imaging.
 
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Brand Name
REAL INTELLIGENCE CHECKPOINT PINS QTY:4
Common Device Name
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
MDR Report Key11340950
Report Number3010266064-2021-00122
Device Sequence Number4760035
Product Code OLO
UDI-Device Identifier00885556757314
UDI-Public00885556757314
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
K201022
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberROB10012
Device Catalogue NumberROB10012
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/26/2021
Supplement Date Received by Manufacturer09/29/2021
Initial Report FDA Received Date02/17/2021
Supplement Report FDA Received Date09/30/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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