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

Catalog Number	ROB10100
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during cori assisted tka surgery, the cori knee tensioner kept disconnecting.For 2 seconds it would act as thought, the piece was connected properly to the system and then would disconnect.The tech disconnected and reconnected the reusable and disposable pieces but this did not work.I tried switching usb ports and this did not work.Surgery was resumed after a non-significant delay by manual procedure.No injuries to the patient were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the cori knee tensioner, part number rob10100, serial number unknown, intended for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.A complaint history review for similar reported/confirmed complaints has identified prior events.While all products met required manufacturing specifications prior to release a serial number, lot number, part revision or software version is required to link the device to a dhr or nc investigation.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical escalation event review was not completed.The product was not returned, and no evidence was made available to link the complaint to an escalation event.We have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with an internal connector associated with the reusable component of the tensioner.Based on the investigation, no containment or corrective action is recommended or required at this time.Should any additional information be received, the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post-market surveillance activities.H10- additional information.D10- concomitant medical products.
Additional Manufacturer Narrative
B5: event description.H11: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Only the gap assessment was performed manually, which is an option within cori.The rest of the procedure was completed with the robot; therefore this event does not qualify as a change from a robotic assisted surgery to a full manual procedure.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
Event or Problem Description
It was reported that during cori assisted tka surgery, the cori knee tensioner kept disconnecting.For 2 seconds it would act as thought, the piece was connected properly to the system and then would disconnect.The tech disconnected and reconnected the reusable and disposable pieces but this did not work.Tech also tried switching usb ports but was unsuccessful as well.Finally, the gap assessment was performed with manually and the surgery was completed with cori after a non-significant delay.No injuries to the patient were reported.

• Brand Name: CORI KNEE TENSIONER
• 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: 19164806
• Report Number: 3010266064-2024-00093
• Device Sequence Number: 7330529
• Product Code: OLO
• UDI-Device Identifier: 00885556809600
• UDI-Public: 885556809600
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2024

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: ROB10100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 05/17/2024; Not provided
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/22/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORI KN TENSIONER: ROB10101, 23FCMX0004.; RI CORI: ROB10024, (B)(6).
• Patient Sex: Unknown