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

Catalog Number 110137

Device Problem Mechanical Jam (2983)

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

Event Date 06/28/2018

Event Type  malfunction  

Event Description

It was reported that, during an ukr surgery, the handpiece jammed when burring the posterior aspect of the femur.It threw the jam error on the screen: after pressing dismiss, the system went back to the connected screen where the handpiece re-calibrated just fine, then went to home, but the drill did not budge an inch.Only the handpiece was swapped out and the rest of the case transferred without any problem.Surgery was not significantly delayed.The patient was not harmed.The results of investigation have pointed out that the snaplock assembly was broken, which makes it a reportable event.

Manufacturer Narrative

The navio handpiece, used in treatment, was jammed and would not home during a procedure.A device history record review found no conditions which could contribute to the reported event and the device met all manufacturing specifications during release for distribution.A complaint history review found similar reports and this issue will continue to be monitored.The navio handpiece was returned for further evaluation and the initial visual/functional inspection was performed, which confirmed the reported event.The snap lock nut was broken.A broken snap lock nut would prevent the snap lock from moving along the lead screw, causing the jam and homing issue.The root cause of this issue was found to be mechanical component failure.

• 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: 9996100
• MDR Text Key: 188859481
• Report Number: 3010266064-2020-00674
• 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
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• 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?: Yes
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1