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

Catalog Number	ROB10015
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during burring of the tibia, the bur fell out of the drill.It is unknown if broken pieces fell into the patient.When attempting to recalibrate the ri robotic drill attachment would not allow the bur to fully seat.The procedure was resumed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Additional Manufacturer Narrative
H3, h6: the ri robotic drill attachment, part number rob10015, serial number sn(b)(6) , intended 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 and service 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 bearing deterioration making it difficult to fully insert the bur.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.H6 (health effect - impact code).
Additional Manufacturer Narrative
H3, h6: the ri robotic drill attachment, part # rob10015, serial # (b)(6), used for treatment, was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.Testing of a known working drill using this drill attachment did not observe any issues with calibrating or loading a bur.Additionally, the bur was not observed to come loose during testing after being properly loaded into the collet.Although the reported problem was not confirmed through a visual or functional evaluation, possible contributing factors may have been related to a fault in either the drill or bur used that prevented proper insertion or seating.This may have been due to a hardware fault, intermittent electrical issue, or even some mechanical blockage.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.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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19305679
• Report Number: 3010266064-2024-00112
• Device Sequence Number: 7243919
• Product Code: OLO
• UDI-Device Identifier: 00885556757345
• UDI-Public: 00885556757345
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2024

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: 04/17/2024
• Supplement Date Received by Manufacturer: 05/28/2024; 07/14/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 05/28/2024; 07/22/2024
• 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: RI CORI: ROB10024, SN (B)(6).
• Patient Sex: Unknown