MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MM X 127MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSD01008

Device Problem Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

Event Description

It was reported that during set up for a navio assisted surgery, it was notices that navio bone pin 4.0mmx152mm (case-(b)(4)), navio bone pin 4.0mm x 127mm (case-(b)(4)) and navio handpiece thumberscrew (case-(b)(4)) had lost their threadings.It is unknown if there was a surgical delay and how the procedure was completed.

Manufacturer Narrative

H3, h6: the navio bone pin 4.0mm x 127mm, part number pfsd01008, lot unk and used for treatment, was not returned for evaluation.A relationship between the reported event and the device could not be established.A visual/functional inspection cannot be completed as no device was returned for evaluation.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, or field service report.A complaint history review for similar reported/confirmed complaints has identified prior events.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is improper method of threading bone pin.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 or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO BONE PIN 4.0MM X 127MM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 12114826
• MDR Text Key: 261476892
• Report Number: 3010266064-2021-00505
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628737
• UDI-Public: 00885556628737
• Combination Product (y/n): N
• PMA/PMN Number: K152574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

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
• Device Operator: Health Professional
• Device Model Number: PFSD01008
• Device Catalogue Number: PFSD01008
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/05/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROB00036/NAVIO SURGICAL SYSTEM INDIA