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 Consequences Or Impact To Patient (2199)

Event Date 01/12/2016

Event Type  malfunction  

Event Description

It was reported that the anspach drill did not slide into the handpiece.Upon inspection, it looked like the blue tip of the handpiece was damaged and the blockage was caused by the bent tip not allowing the long attachment to pass through freely.As this happened during set up, the patient was not involved at the time.

Manufacturer Narrative

H10: the device, intended for use in treatment, was not made available to the designated complaint unit for evaluation.Thus, visual and functional inspection could not be performed.It was reported that during setup, the anspach drill did not slide into the handpiece.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.A complaint history review found no similar report, this issue will continue to be monitored.A relationship between the device and the reported event could not be established.Factors that could have contributed to the reported issues are mechanical component failure from bending of the handpiece drill guide support or if debris was stuck in the drill guide support.The material of the drill guide support has been changed from aluminum to stainless steel to increase durability and reduce deformation in the field.No further containment or corrective actions are recommended at this time.

• 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: 9997688
• MDR Text Key: 189581374
• Report Number: 3010266064-2020-00297
• 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: 07/31/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 110137
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1