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 Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, before a navio tka procedure, the bur could not be inserted into the long attachment.They tried both ways just to make sure.It looks like the internal parts have shifted to block the entry.There was a delay of fewer than 30 minutes.It was swapped for its backup to proceed.No patient was involved at the moment.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: the navio long attachment part number 110006 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.The reported problem was confirmed.The internal bearings are disintegrated causing an obstruction in 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 "connection problem, break" and "connection problem - instrument", "damaged or broken component", "functional - loose" identified 76 similar events between (b)(6) 2017 to (b)(6) 2020.The most likely cause of this event is degradation/collapse of the long attachment internal bearings making insertion difficult or not possible.Further investigation into the reported failure is being conducted to determine if additional actions are required.

• 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: 10784418
• Report Number: 3010266064-2020-01954
• Device Sequence Number: 3525796
• Product Code: OLO
• UDI-Device Identifier: 00885556628607
• UDI-Public: 00885556628607
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 03/02/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1