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

Model Number ROB10015

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 11/02/2020

Event Type  Injury  

Event Description

It was reported that, after the case, while troubleshooting the drill via the drill diagnostics and received "robotic drill critical error." they could not get the burr out (stuck in the drill attachment, so the attachment would not come off, and therefore, the tracker array could not be taken off.No case involved.

Manufacturer Narrative

H3, h6: the ri robotic drill attachment, rob10015, (b)(6) intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually confirmed.The drill, drill attachment, and drill array are stuck together.A functional evaluation was performed.The drill was disassembled and the drill attachment was removed.The drill wave spring was assembled backwards.A kpc test was performed and passed.The drill attachment functions as intended without any issues.The most likely cause of this event is production incorrectly assembled the wave spring onto the nose piece.Incorrect assembly places the wave part of the spring adjacent to the top retaining ring.The diameter of the wave spring is greater/wider than the retaining ring.As a result the wave spring can then pop up over the retaining ring and cause the drill attachment to become stuck to the drill.A review of the assembly procedure confirmed steps to ensure proper assembly of the wave spring.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.Refer to the real intelligence cori for knee arthroplasty user manual, section assembling the robotic drill for proper handling.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from the us, it was reported that while starting a case for a cori tka procedure, they received several error messages.They decided to switch to navio as they did not have any more sterile cori trays.There was no injury to the patient and very minimal delay (fewer than 30 minutes).After the case, they could not get the burr out (stuck in the drill attachment), so the attachment would not come off, and therefore, the tracker array could not be taken off.No other complications were reported.As a part of corrective action a change has been made to the assembly process to improve installation instructions.The failure mode will continue to be monitored through complaint investigation and trended through post market surveillance activities.

• 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: 10875069
• MDR Text Key: 217322624
• Report Number: 3010266064-2020-02018
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757345
• UDI-Public: 00885556757345
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10015
• Device Catalogue Number: ROB10015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• 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: Reuse
• Patient Sequence Number: 1