MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO TKA DISTAL FEMUR PUNCH - 45MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB00061
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	02/01/2021
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 procedure, the surgeon realized there was some play with the punch tool.He was anterior 1.5 mm after carefully seating and malleting the punch tool in the femoral lugs, which were prepared with a 5mm bur.The case was set for legion ps.The bone was hard.He moved the distal cutting block posterior to correct this, as confirmed with the plane visualization tool.Delay reported less than 30 minutes.No patient harm or additional complications were reported.
Additional Manufacturer Narrative
H3, h6: the navio tka distal femur punch - 45mm, rob00061, used in treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A log file review was performed.The reported problem was not confirmed.The provided log files did not reveal any further information regarding the reported complaint event.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 concluded this was an isolated event.Although the reported problem was not confirmed, no reasonable contributing factors could be identified based on the received complaint information and investigation results.An escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.The navio surgical system is a surgical tool designed to assist the surgeon; it is not a substitute for the surgeon¿s experience and skill.The surgeon retains all responsibility for the planning and the conduct of the surgery during which the navio surgical system is being used.This failure is an identified failure mode within the risk assessment.It was communicated that the requested medical documentation was not available for inclusion in the medical investigation and the device would not be returning for evaluation.Based on the information provided, the patient impact beyond the reported cutting block intervention could not be determined,as reportedly, there was no patient injury/harm or other complications.No further medical assessment is warranted at this time.Should additional information/documentation become available, the clinical/medical task may be re-opened for further evaluation.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: NAVIO TKA DISTAL FEMUR PUNCH - 45MM
• 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: 11381243
• Report Number: 3010266064-2021-00134
• Device Sequence Number: 4567966
• Product Code: OLO
• UDI-Device Identifier: 00885556709405
• UDI-Public: 00885556709405
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• 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): 05/12/2022

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: ROB00061
• Device Catalogue Number: ROB00061
• 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: 02/01/2021
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 05/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ROB20000/CORI ROBOTICS USA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown