MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CHECKPOINT TOOL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10022
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a cori assisted tka surgery, the surgeon successfully put one checkpoint pin into the femur using the real intelligence checkpoint tool.The surgeon then tried to move on to put in the second checkpoint pin, however the checkpoint pin would not release from the tool after being malleted into the tibia.The surgeon was able to disconnect the checkpoint pin from the tool using brute force, however it pulled the checkpoint pin out of the bone when doing so.It was tried again with a different checkpoint pin with no change.The procedure was completed, without significant delays, by inserting the second checkpoint pin in a new spot, with a kocher instead of the checkpoint tool.Patient was not harmed beyond the reported issue.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the real intelligence checkpoint tool, rob10022, lot 20ect0019, used for treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.When malleting a checkpoint pin into a piece of delrin (simulated bone), the pin got stuck on the checkpoint tool and took some force to remove.It was noticed under a microscope that there is a worn groove on the inside of the tool.The most likely cause of this event is wear and tear.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.Refer to the product instructions for use.Care and caution should be exercised when handling instruments from the tray during setup, takedown, decontamination and sterilization.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details, the second checkpoint pin would not release from the tool after being malleted into the tibia which, when removed with force also removed the checkpoint pin and required an additional pin, bone hole, and a kocher (instead of the checkpoint tool) to complete the procedure.Reportedly, the procedure was completed using the backups as above without significant delay or additional patient harm.It was communicated that the requested clinical information was not available.Without the requested documentation, the root cause of the reported event could not be definitively concluded.Patient impact beyond the reported additional pin, bone hole, surgical delay <30 minutes and subsequent change in technique using the backup tool/kocher could not be determined.No further medical assessment could be rendered at this time.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.

• Brand Name: REAL INTELLIGENCE CHECKPOINT TOOL
• 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: 13537174
• Report Number: 3010266064-2022-00101
• Device Sequence Number: 19878462
• Product Code: OLO
• UDI-Device Identifier: 00885556757413
• UDI-Public: 00885556757413
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ROB10022
• Device Catalogue Number: ROB10022
• Device Lot Number: 20ECT0019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 06/12/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB20000-CORI ROBOTICS USA.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown