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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).Article cite: mergenthaler, g., batailler, c., lording, t., servien, e., & lustig, s.(2021).Is robotic-assisted unicompartmental knee arthroplasty a safe procedure? a case control study.Knee surgery, sports traumatology, arthroscopy : official journal of the esska, 29(3), 931¿938.Https://doi.Org/10.1007/s00167-020-06051-z.
Event or Problem Description
It was reported that, on the literature review "is robotic-assisted unicompartmental knee arthroplasty a safe procedure? a case control study", four (4) uka procedures assisted with a blue belt navio robotic surgical system were aborted and completed with conventional instrumentation.One (1) of these cases was aborted because the tibial tracking array was accidentally moved during surgery, making the rest of the surgery impossible with the robotic assisted system.No further information is available.
Additional Manufacturer Narrative
The navio tibia tracker array, part number pfsr110018, intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.The clinical/medical investigation concluded that no patient specific documentation was provided as of the date of this medical investigation; therefore, there were no clinical factors found which would have contributed to the event.With the information provided, the patient impact beyond that which was reported cannot be determined.No further medical assessment can be rendered at this time.A complaint history review for similar reported/confirmed complaints has identified prior events.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 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.As a result of the risk assessment the quality team has been notified for further investigation.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with 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.Internal complaint reference number: case-2022-00116613-1.

• 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: 15251912
• Report Number: 3010266064-2022-00573
• Device Sequence Number: 5847796
• Product Code: OLO
• UDI-Device Identifier: 00885556628546
• UDI-Public: 00885556628546
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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: 11/06/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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