MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CHECKPOINT PINS QTY:4; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our reference number: case-(b)(4).
Event or Problem Description
It was reported that during cori tka journey bcs procedure when advanced to the visualize plane screen for the tibia as the surgeon was setting up his jig, the plane checker showed significant deviation from the planned planes.The surgeon didn¿t trust it, and they went to verify checkpoints.They failed the femur checkpoint four times at 3.5mm.They were using the 152mm cori bone pins in the femur and the clamp was tightened as high as it could go distal to the black laser etch line.The thigh of the patient was large and the bone pins were placed on the anterior femoral shaft.They suggested to place them within the metaphysics on his larger patients, but he objected that he would need to make a larger incision to accommodate this placement.The case was continued with manual procedure (finished the tibia using the jig without cori navigation) without delays or additional complications.
Additional Manufacturer Narrative
Section h10: the real intelligence checkpoint pins qty:4 used for treatment were not made available to the designated complaint unit for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints found 1 similar event.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may have been associated with tracker array movement.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.The user manual provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines".The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.Internal complaint reference number: (b)(4).

• Brand Name: REAL INTELLIGENCE CHECKPOINT PINS QTY:4
• 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: 11447793
• Report Number: 3010266064-2021-00177
• Device Sequence Number: 14337506
• Product Code: OLO
• UDI-Device Identifier: 00885556757314
• UDI-Public: 00885556757314
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K201022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ROB10012
• Device Catalogue Number: ROB10012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 03/31/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown