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

Model Number	PFSR110006
Medical Device Problem Codes	Break (1069); Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a navio-assisted tka surgery, the navio long attachment made it difficult to insert the spherical drill into its place and lock it on the handpiece.The procedure was finished with manual instrumentation without significant delays (fewer than 30 minutes).The patient was not harmed.
Additional Manufacturer Narrative
H3, h6: the navio long attachment (poland), product: pfsr110006, used in treatment was not made available to the designated complaint unit for evaluation, however visual inspection was possible with 4 photos.A relationship between the reported event and the device could not be visually confirmed through photos as only the exterior was shown.A functional evaluation could not be performed because the device was not returned.A review of manufacturing and service 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.Although the reported problem was not confirmed a factor that may have contributed to the reported symptom may have been associated with mechanical component failure of the bearings due to natural wear and tear.Refer to the navio surgical technique guide (500197) that provides guidelines for recovering to a fully manual procedure from a system failure.This failure is an identified failure mode within the risk assessment.There was a surgical delay of 30 minutes or less and the case was completed with manual instrumentation.No patient injury or impact was reported and it was noted that the patient is recovering well following surgery.Smith & nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received the complaint can be reopened.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO LONG ATTACHMENT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 11891111
• Report Number: 3010266064-2021-00420
• Device Sequence Number: 1388162
• Product Code: OLO
• UDI-Device Identifier: 00885556628607
• UDI-Public: 00885556628607
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K160537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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: PFSR110006
• Device Catalogue Number: PFSR110006
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention