MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES CORI KNEE TENSIONER CARTRIDGE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	ROB10101
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reference number: (b)(4).
Event or Problem Description
It was reported that during cori assisted tka surgery, the cori knee tensioner cartridge did not fit into tensioner.Surgery was resumed after a non-significant delay by manual procedure.Patient was not harmed as consequence of the problem.
Event or Problem Description
It was reported that during cori assisted tka surgery, the cori knee tensioner cartridge did not fit into tensioner.Surgery was resumed after a non-significant delay with manual gap assessment (meaning, the tensioner was not used), but the procedure was concluded with cori.Patient was not harmed as consequence of the problem.
Additional Manufacturer Narrative
H10: corrected event description in b5 and corrected section h6.Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the tka surgery was completed with cori, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.

• Brand Name: CORI KNEE TENSIONER CARTRIDGE
• Common Device Name: ORTHOPEDIC 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 Key: 18436913
• Report Number: 3010266064-2024-00005
• Device Sequence Number: 15191063
• Product Code: OLO
• UDI-Device Identifier: 00885556809655
• UDI-Public: 885556809655
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K221224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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 Catalogue Number: ROB10101
• Device Lot Number: 23ECMX0006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB10024.
• Patient Sex: Unknown