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

Model Number PFSDV0016

Device Problem Off-Label Use (1494)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2020

Event Type  malfunction  

Event Description

It was reported that a box of flat markers had been used beyond its expiration date.The customer kept them on their shelf and obtained restock from the office.It was noticed during the setup of an ukr procedure, that the devices had expired in february 2020.This is the eighth of eight boxes used.

Manufacturer Narrative

The navio flat markers, part pfsdv0016 intended for use in treatment were not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed.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 has identified prior events.Although the reported problem was not confirmed a contributing factor may be customer did not manage product expiration on shelf.No containment or corrective actions are recommended at this time.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO FLAT MARKERS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10228576
• MDR Text Key: 197579273
• Report Number: 3010266064-2020-01632
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628904
• UDI-Public: 00885556628904
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: PFSDV0016
• Device Catalogue Number: PFSDV0016
• Device Lot Number: 232106018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1