MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSR110137

Device Problems Break (1069); Appropriate Term/Code Not Available (3191); Physical Resistance/Sticking (4012)

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

Event Date 06/26/2019

Event Type  Injury  

Event Description

It was reported that the hanpiece calibration was fine, but starting drilling the distal bur , the hanpiece got stuck an error message appeared on screen.After checking that the problem was not solvable on the spot, the surgery has been converted to manual procedure.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that procedure was completed with standard smith&nephew instrumentation, and it is considered an approved technique if navio system is not used, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

Event Description

It was reported that the hanpiece calibration was fine, but starting drilling the distal bur, the hanpiece got stuck an error message appeared on screen.After checking that the problem was not solvable on the spot, the surgery has been converted to manual procedure using smith & nephew instrumentation.

Event Description

It was reported that the handpiece calibration was fine, but starting drilling the distal bur , the handpiece got stuck and an error message appeared on screen.After checking the problem was not solvable on the spot, the surgery has been converted to manual procedure using smith & nephew instrumentation.Investigation results determined that black snap lock nut was broken, which makes it a reportable event along with the manual procedure.

Manufacturer Narrative

H10: a1, a3: updated information.H11: b1, b2, b5, e2, e3, g3, g5, h1, h3, h6: corrected information.

Manufacturer Narrative

Additional info: d10, g4, g7, g9, h2, h3, h6, h10.Results of investigation:the navio handpiece, used in treatment, was returned for further evaluation and a visual and functional evaluation was performed, which confirmed the reported event.Visual inspection confirmed that the snap lock nut was broken.This would have caused an error when the user started burring because the handpiece would not be able to properly move the drill for burring.This likely caused a handpiece jam error.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 263 similar reports and this issue will continue to be monitored.The navio surgical system user¿s manual (500196 rev.A) was reviewed and there was no information regarding the snap lock nut which broke off of the snap lock.Additionally, product labeling has been ruled out as an issue for this complaint.This failure is captured in the navio risk profile.Per complaint details, although there was an unresolved hand-piece error, the surgeon converted to manual instrumentation to complete the procedure without delay and with no patient impact/injury.Per previous product evaluation, the ¿snap lock nut was broken¿ and likely caused the error.Based on this information, no further medical assessment is warranted at this time.The root cause was found to be mechanical component failure.As part of corrective actions, a new and more robust design of the snap lock has been released.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 8824457
• MDR Text Key: 157827253
• Report Number: 3010266064-2019-00102
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention