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

Model Number PFSR110137

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2020

Event Type  malfunction  

Event Description

It was reported that, during a navio procedure, it was noticed that the anspach drill kept becoming unlocked while the surgeon was burring.They suspect that the ball detent mechanism inside the handpiece was worn out (or loose) and wasn't holding the long attachment in place.The surgeon moved a lot slower than usual while burring to prevent further unlocking (this reduced the efficiency of the surgeon's burring, but there was no impact on the outcome).There was a delay of fewer than 30 minutes.After the case, they inspected the handpiece and found that the locking mechanism holding the long attachment in place was indeed very loose.No other complications were reported.

Manufacturer Narrative

The navio handpiece, part number pfsr110137, (b)(6) and used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was confirmed.The evaluation followed a performance verification.The drill feels loose in the snap lock upon attempting to secure drill into position within handpiece.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most probable cause of the reported problem is loose handpiece snaplock due to normal wear and tear.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.

• 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: 10778742
• MDR Text Key: 214349942
• Report Number: 3010266064-2020-01948
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1