MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 110137

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2019

Event Type  malfunction  

Event Description

It was reported that during training, it was discovered that anspach drill would not couple with the navio handpiece.The handpiece showed damaged on the clamshell.It is unknown how the training continued.Investigation results determined that clamshell damages seen on the pictures provided were the ones responsible for the drill unable to attached properly.

Manufacturer Narrative

H10: the device, intended for use in treatment, was not returned for investigation.A device history record review was not performed since there the record could not be located at this time and it could not be concluded if the device met the manufacturing specifications.A complaint history review found similar reports and this issue will continue to be monitored.The navio handpiece was not returned for further evaluation and an initial visual inspection was performed using the photos sent with the field report, which confirmed the relationship between the device and reported event.The photos confirmed damage to the handpiece clamshell.It appears that the handpiece was clamped, causing the damage and there are several scratches on the outside of the handpiece.The photo of the closed handpiece showed that it was so misshaped that the clamshell could not be properly closed.The malfunction is likely due to user error.

• Brand Name: HANDPIECE, NAVIO (BBT HANDPIECE), ROHS COMPLIANT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9994065
• MDR Text Key: 189913239
• Report Number: 3010266064-2020-01027
• 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,other
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

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: 110137
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention