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

Model Number PFSR110137

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2020

Event Type  malfunction  

Event Description

It was reported that during burring of the femur in a navio ukr procedure, the drill consistently unlocked from the handpiece.The surgeon had to consistently re-assemble and lock the drill in.We ensured the drill was properly locked in before resuming, and the unlocking would continue to occur.There was a delay of less than 30 minutes, no impact to the patient and the procedure was completed with the same device.No other complications were reported.

Manufacturer Narrative

H3, h6: the navio handpiece part number 110137, sn: (b)(6), used for treatment, was returned for evaluation.The reported problem was not confirmed visually.A functional evaluation was performed.The evaluation followed the handpiece performance evaluation.The reported problem was not confirmed.The snap lock/drill interface appears to be working properly.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 factors that may have contributed to the reported symptom may have been a failure to follow instructions.Ensure that the final position of the drill is between 9:00 and 12:00 positions when viewed from the rear perspective.The arrow should not be visible on the left side when viewed from the rear.Based on the investigation, no further containment or corrective action is recommended or required at this time.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10670958
• MDR Text Key: 211500624
• Report Number: 3010266064-2020-01855
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1