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

Catalog Number 110004

Device Problem Defective Component (2292)

Patient Problem No Information (3190)

Event Date 12/29/2014

Event Type  Injury  

Event Description

It was reported that the handpiece could be calibrated but it did not home.The long attachment and bur were disassembled and assembled but it did not work.Another handpiece and drill were used but they did not home.The instruments were lubricated but it did not work.The handpiece seemed to not hold the drill and lock it.One drill kept spinning and not locking, the other one was very difficult to push in and lock but would lock.A new long attachment was going to be used but the tip was severed right in half clean cut off tip making impossible the use.The case was completed using manual instruments.Results of investigation have concluded that the drill guide support on the handpiece was bent, which makes it the root cause of the device malfunction.Patient injuries were not reported beyond this event.

Manufacturer Narrative

H10: the device, used in treatment, was returned for investigation.The probable cause of the issue was a mechanical component failure.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history review found a similar report as this was the only complaint for the reported issue, this issue will continue to be monitored.The surgical technique guide released at the time of the complaint provides instructions for using the handpiece.This failure is an identified failure mode within the risk file.A relationship between the device and the reported event could be established.The initial visual/functional investigation found that: handpiece a (b)(6) reportedly was not locking into place nor homing.This is due to the snap lock having been broken.The drill carrier was not attached to the rest of the snap lock assembly thus the drill had nothing to snap into.Furthermore, with the drill not being extended/retracted, the lead screw nut was able to move the full length of the lead screw during homing thus exceeding the expected range (10.925mm) and traveling the full range (~14.26mm).This would result in the failed homing.The malfunction is likely due to mechanical component failure from bending of the handpiece drill guide support.The material has been changed to stainless steel to increase durability and reduce deformation in the field.Per complaint details, currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Based on the information provided, the procedure change/subsequent modified procedure, and the reported delay did not result in patient injury/impact; therefore, no further medical assessment is warranted at this time.

• 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: 9996812
• MDR Text Key: 188874306
• Report Number: 3010266064-2020-00142
• 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: 08/25/2020

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 110004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2014
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1