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

Catalog Number	ROB10015
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a cori assisted tka, the burr was inserted properly into the ri robotic drill attachment and was able to successfully calibrate and retract.However, when going to distal cut, the burr disengaged the handpiece and fell out onto the sterile field.When the burr was reinserted and recalibrated, it was sitting up ~2mm.The case was completed and the drill was tested and it passed the kpc test.The procedure was resumed, after a significant delay, using the same device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Additional information: h3, h6, h11.H11: the ri robotic drill attachment, part number rob10015, serial number (b)(6), intended for treatment was returned for evaluation.The reported problem could not be confirmed with a visual inspection.Nothing was visually identified that leads to the reported scenario.The reported problem was not confirmed with a functional evaluation.A test kpc and a mock tka case was performed with the long attachment connected.No issues were observed during the load and spinning test of the burr.The long attachment connected and disconnected from the drill as intended, with secure and proper engagement.The long attachment was disassembled for further investigation.No issues were observed with the internal components, and loctite was present on the retaining nut.A complaint history review was performed by part number and no similar complaints were identified.A review by lot/serial number was performed and no similar complaints were identified.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 an improper assembly process.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: RI ROBOTIC DRILL ATTACHMENT
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24752445
• Report Number: 3010266064-2026-00065
• Device Sequence Number: 13296738
• Product Code: OLO
• UDI-Device Identifier: 00885556757345
• UDI-Public: 885556757345
• 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
• Report Date (Section B): 04/28/2026

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: ROB10015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/28/2026
• 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: PART#: ROB10024, SN: (B)(6)
• Patient Sex: Unknown