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

Catalog Number 110137

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 04/29/2016

Event Type  malfunction  

Event Description

It was reported that during the sterilization process, the tip of the handpiece where the end of the drill sticks out was bent.The drill was not assembly with the handpiece, but i suspect it may not have been able to fit or would at least be too tight to home properly.There is no patient involved.

Manufacturer Narrative

H10: the device, intended for use in treatment, was returned for evaluation.Device history record review found that the device met the manufacturing specifications.A complaint history review found similar reports, this issue will continue to be monitored.The initial visual/functional investigation visually confirmed that the drill guide support was bent.The probable cause of the issue was a mechanical component failure.A relationship between the device and the reported event could be established.The drill guide is made of aluminum, and the material has been changed to stainless steel to increase durability and reduce deformation in the field.

• 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: 9997697
• MDR Text Key: 188895782
• Report Number: 3010266064-2020-00304
• 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: 08/31/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1