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

Model Number	PFSR110006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The navio long attachment intended for use in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The evaluation followed the long attachment performance verification procedure.The reported problem was not confirmed.The long attachment was attached and detached to the handpiece with no problems.In addition, a functional evaluation was performed on the part beyond the reported complaint.The internal bearings are disintegrated causing an obstruction in the long attachment.The bur could not be inserted into the long attachment.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints associated with the part with the failure modes "no apparent adverse event" and "connection problem - instrument" identified similar events.A relationship between the reported event and the device could not be established as there was no damage or problem found with the device during the visual and functional inspection.Although the reported problem was not confirmed contributing factors may be the handpiece snap lock mechanism tolerance or the user failed to insert the drill/long attachment in the optimum orientation (triangle on drill in 6-11 o'clock position when facing rear of handpiece) to secure the drill/long attachment to the handpiece snap lock.Consult the navio user manual to review the process to confirm the drill/long attachment is securely attached to the handpiece.No containment or corrective actions are recommended at this time.Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that before a tka procedure, the long attachment would not properly attach to the handpiece.They opened open another tray to get a new long attachment that would work to continue the procedure without delay.No other complications were reported.The investigation found that the internal bearings are disintegrated causing an obstruction in the long attachment.

• 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: 11478055
• Report Number: 3010266064-2021-00183
• Device Sequence Number: 19764288
• Product Code: OLO
• UDI-Device Identifier: 00885556628607
• UDI-Public: 00885556628607
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PFSR110006
• Device Catalogue Number: PFSR110006
• Device Lot Number: 79780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1