MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number ROB10015

Device Problems Connection Problem (2900); Mechanical Jam (2983); Unintended Application Program Shut Down (4032)

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

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, during a cori assisted tka, the bur stopped working and the real intelligence robotic drill showed a disconnect error during distal femur resection; then, an internal error message came up when trying to restart.The procedure was resumed, after a non-significant delay, by switching to manual procedure.No patient injury was reported due to this issue.After the procedure, it was noticed that it was not possible to remove the bur or the ri robotic drill attachment from the robotic drill, not even with the drill diagnostic function.

Manufacturer Narrative

Section h10: the ri robotic drill attachment, part number (b)(4), serial number (b)(6), used 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.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 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 a loose drill attachment retaining nut.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.Internal complaint reference number: (b)(4).

• Brand Name: RI ROBOTIC DRILL ATTACHMENT
• 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: 18429930
• MDR Text Key: 331820058
• Report Number: 3010266064-2024-00002
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB10015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: RI CORI CONSOLE(PN:ROB10024,SN(B)(6)).; RI ROB DRILL(PN:ROB10023,SN(B)(6)).; RI ROB DRL TRCKR(PN:ROB10014)