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

Catalog Number PFSR110004

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2018

Event Type  malfunction  

Event Description

It was reported that, during a tka surgery, the handpiece did not home.When checked the bur, drill, and handpiece, the situation could not be changed.After exchanging handpieces, there was not any problem with homing.The handpiece was tested and it showed a torque value of 58.Surgery was delayed, but it is unknown for how long.The patient was not harmed.

Manufacturer Narrative

The device was used during treatment and was returned for a prior investigation.The functional inspection of the returned handpiece found that after autoclaving and cooling down, the handpiece motor required higher than normal torque to move.This is indicative of a motor issue.The dhr was reviewed and the reported product met manufacturing specifications prior to be released for distribution.A complaint history review found similar complaints of the reported issues.The relationship of the device and the reported event has been established.Typically, we have seen that the motor will break free and become operable after a second or third characterization test.The root cause of the reported event was due to mechanical component failure.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9988794
• MDR Text Key: 188669572
• Report Number: 3010266064-2020-00621
• Device Sequence Number: 1
• Product Code: OLO
• 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: 08/10/2020

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 Catalogue Number: PFSR110004
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR