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

Catalog Number PFSR110137

Device Problem Defective Component (2292)

Patient Problem Injury (2348)

Event Date 03/19/2018

Event Type  Injury  

Event Description

It was reported that during a surgical procedure, the black drum into the handpiece was wobbling.The surgeon decided to change to a manual procedure.No patient injuries reported beyond this event.Results of the investigation have concluded that the snaplock assembly was broken, which makes it a reportable event.

Manufacturer Narrative

H10: h3, h6: the navio handpiece, used in treatment, was return for evaluation.The navio handpiece [?]s snap lock nut was wobbly in the handpiece during a procedure.A device history record review found no conditions which could contribute to the reported event and the device met all specifications during release for distribution.A complaint history review found similar reports and this issue will continue to be monitored.The navio surgical system for unicondylar knee replacement and patellofemoral arthroplasty user's manual (500054 rev.G) released at the time of the complaint provided no information regarding the snap lock nut which broke off the snap lock.This failure is captured in the navio risk profile.The navio handpiece was returned for further evaluation and the initial visual/functional investigation confirmed that the snap lock nut had broken off the snap lock.The root cause of this issue was found to be 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: 9993743
• MDR Text Key: 188839110
• Report Number: 3010266064-2020-00166
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention