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

Catalog Number	ROB10015
Medical Device Problem Codes	Positioning Failure (1158); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during set up/inspection for cori assisted tka surgery, one (1) real intelligence robotic drill would not accept two (2) ri robotic drill attachments, it was unsuccessful.It was able to get a third attachment on, with some force; however, after doing it, it became stuck on the drill and needed to go into kpc test in order to remove it.The procedure was performed, after a non-significant delay, with a change in the surgical technique: the surgeon canceled cori and used visionaire instead, as originally schedule.It was later converted into a cori, then the cutting blocks had already been manufactured.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Additional information: d9.Correction: d1, d4, d10.Internal complaint reference: case-(b)(4).
Additional Manufacturer Narrative
Correction: g4 internal complaint reference: case-(b)(4).
Additional Manufacturer Narrative
H3, h6: the ri robotic drill attachment, part number rob10015, serial number (b)(6), intended for use in treatment, was returned for evaluation.The reported problem was visually confirmed.The retaining nut of the attachment is installed upside down, and when the attachment is shaken bearings and spacers inside can be heard rattling.A functional evaluation was performed.The reported problem was confirmed.The attachment could not be locked onto a drill due to the reversed retaining nut.No other issues were observed with the attachment.The most likely cause of the reported issue was found to be due to the retaining nut of the drill attachment being installed backwards.Since the drill attachment could not have passed through functional checks before being released as a 100% check is performed for this dimension, it is unreasonable to assume the retaining nut was installed that way during production or service.It is more likely that the retaining nut came loose due to fatigue or was removed from the drill attachment, and then was reinstalled in the wrong orientation.As similar issues were reported from the same site previously, it is possible that attempted self repairs were being performed by a technician onsite.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review was performed by part number and similar complaints were identified.A review by serial number was performed and no similar complaints were identified.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.The failure mode and associated risk have been anticipated within the risk file including a documented risk level.Although no further containment or corrective action is recommended or required at this time, 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: 21940233
• Report Number: 3010266064-2025-00096
• Device Sequence Number: 21033221
• Product Code: OLO
• UDI-Device Identifier: 00885556757345
• UDI-Public: 885556757345
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 08/01/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 07/11/2025; 07/11/2025; 07/29/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 07/28/2025; 07/28/2025; 08/01/2025
• 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: REAL INTELLIGENCE CORI: ROB10024, (B)(6).; REAL INTELLIGENCE CORI: ROB10024, (B)(6).; REAL INTELLIGENCE ROBOTIC DRILL: ROB10013,(B)(6).; RI ROBOTIC DRILL ATTACHMENT: ROB10015, (B)(6).; RI ROBOTIC DRILL ATTACHMENT: ROB10015, (B)(6).; RI ROBOTIC DRILL ATTACHMENT: ROB10015, (B)(6).
• Patient Sex: Unknown