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

Catalog Number UNKNOWN

Device Problems Failure to Recalibrate (1517); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2015

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure, there were homing failures.Troubleshooting was applied but the handpiece had to be changed.It is unknown the length of the surgical delay.No patient injuries reported.Results of the investigation have concluded that the snaplock assembly was damaged, which makes it a reportable event.

Manufacturer Narrative

H10: the navio handpiece (part number 110137 / serial number (b)(6)), intended for use in treatment, had homing failure during a procedure on (b)(6) 2015.The navio handpiece was not returned for further evaluation and a visual/functional inspection could not be performed.During an internal analysis, the problem was determined to be caused by the material used to manufacture one of the snap lock components.The material used by one of the suppliers is displaying properties after autoclave sterilization that may cause the snap lock assembly to become tight.This handpiece had a snap lock from one of the affected lots.The root cause of this issue was found to be supplier/raw material fault.A device history record review was not performed since there was no part/serial/lot number provided 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.

• Brand Name: HANDPIECE, NAVIO (BBT HANDPIECE)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9984496
• MDR Text Key: 188669081
• Report Number: 3010266064-2020-00223
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2015
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1