MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSR110137
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2020
Type of Reportable Event	Serious Injury
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 due to the burr rotating too fast, leading to an overheating of the robotic handpiece and making necessary to stop this system before bone resection.No further information is available.
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.
Additional Manufacturer Narrative
Section h10: the navio handpiece, part number pfsr110137, intended 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 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.Refer to the navio surgical system user¿s manual, section assembling the hardware, assembling the handpiece for proper set up and handling.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 failure of the anspach drill or the drill thermistor that monitors drill temperature.As the bur spins fast the drill overheats, overheating the handpiece as well as they are assembled together.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 (b)(4).

• Brand Name: NAVIO HANDPIECE
• 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: 15246071
• Report Number: 3010266064-2022-00566
• Device Sequence Number: 15088293
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

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: PFSR110137
• Device Catalogue Number: PFSR110137
• 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: 10/23/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 10/28/2022
• 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