MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE 6 MM CYLINDRICAL BUR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10036
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference: (b)(4).
Event or Problem Description
It was reported that during a cori-assisted tka, when burring the real intelligence 6 mm cylindrical bur fell out.The bur broke at end.A small tip was stuck in drill collet, retrieve and removed from field.Surgery was performed after a non-significant delay, with a back-up device.No patient complications were reported.
Additional Manufacturer Narrative
The real intelligence 6 mm cylindrical bur, part # rob10036, lot # 1125569, intended for use in treatment, was returned for evaluation.The reported problem was visually confirmed.The bur's insertion tip which locks into the the drill collet was detached from the bur shaft and still lodged into the collet of returned drill (b)(6).Functional evaluation could not be performed due to broken/damaged parts.The most likely cause seems to have been from an unexpected material fracture, possibly due to high torsional forces acting on the anchoring point when burring.A review of manufacturing 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: REAL INTELLIGENCE 6 MM CYLINDRICAL BUR
• 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: 16986589
• Report Number: 3010266064-2023-00092
• Device Sequence Number: 15171372
• Product Code: OLO
• UDI-Device Identifier: 00885556757512
• UDI-Public: 00885556757512
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/13/2023

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 Model Number: ROB10036
• Device Catalogue Number: ROB10036
• Device Lot Number: 1125569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 06/11/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/13/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB10013 / SERIAL NUMBER (B)(6).; ROB10024 / SERIAL NUMBER / (B)(6).
• Patient Sex: Unknown