MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO TIBIA TRACKER ARRAY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSR110018
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	06/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On the literature review "the successful implementation of the navio robotic technology required 29 cases", it was reported that one (1) patient experienced tibial array displacement during a navio-assisted ra-tka procedure.This event was solved by converting the procedure to a manual tka.No further information is available.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
B5: event description.
Event or Problem Description
On the literature review "the successful implementation of the navio robotic technology required 29 cases", it was reported that one (1) patient experienced tibial array displacement during a navio-assisted ra-tka procedure.Due to this displacement, landmarks could not be verified.This event was solved by converting the procedure to a manual tka.No further information is available.
Additional Manufacturer Narrative
The navio tibia tracker array, part number pfsr110018, used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.While all products meet required manufacturing specifications prior to release a serial number, lot number, part revision or software version is required to link the device to a dhr or nc investigation.The navio surgical technique guide for knee arthroplasty (500197 rev c) 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.The risk level is still adequate.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 loose tibial tracking array.Based on the investigation, the need for a corrective action is not 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.

• Brand Name: NAVIO TIBIA TRACKER ARRAY
• 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: 15246078
• Report Number: 3010266064-2022-00565
• Device Sequence Number: 6540956
• Product Code: OLO
• UDI-Device Identifier: 00885556628546
• UDI-Public: 00885556628546
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Literature,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2022

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: PFSR110018
• Device Catalogue Number: PFSR110018
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 10/12/2022; 10/23/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 10/17/2022; 10/25/2022
• 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