MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE TRACKER CLAMP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number ROB10020

Device Problem Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2023

Event Type  malfunction  

Event Description

It was reported that during a cori-assisted tka, when tightening the real intelligence tracker clamp, it was ensured that the clamps were tightened down.However, when they were going to cut the tibia and checking their checkpoints, it was received an error that the tibia array had moved tried to verify checkpoints and it did not allow to proceed.They had to restart the case then it was noticed that the tibial tracking array was loose.The device was retightened proceeded with the case as normal causing a minimal delay.No patient complications were reported.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Manufacturer Narrative

H3, h6: the real intelligence tracker clamp, part number rob10020, lot number 22kct0003, used for treatment was returned for evaluation.The reported problem could not be confirmed with a visual inspection.The reported problem was not confirmed with a functional evaluation.The tracker clamp was installed and a case was initiated.The case was completed successfully.The tracker clamp securely grasps and holds a tracker.The fastener does not loosen or vibrate loose.A relationship between the reported event and the device could not be established as there was no damage or problem found with the device during the visual and functional inspection.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.A review of manufacturing records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.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 a worn tracker or insufficient torque applied to the tracker clamp.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.

• Brand Name: REAL INTELLIGENCE TRACKER CLAMP
• Type of Device: 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: 18149278
• MDR Text Key: 328290477
• Report Number: 3010266064-2023-00201
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757390
• UDI-Public: 885556757390
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB10020
• Device Lot Number: 22KCT0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: PN: ROB10024 / SN: (B)(6).