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

Catalog Number 110137

Device Problem Defective Component (2292)

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

Event Date 08/31/2018

Event Type  Injury  

Event Description

It was reported that during a surgical procedure, the drill kept popping out of the back of the handpiece.The surgeon did not want to wait for a new handpiece and lost trust in the system so he switched to manual instrumentation.No patient injuries reported beyond this event.Results of the investigation have concluded that the snaplock assembly has incorrect dimensions, which makes it a reportable event.

Manufacturer Narrative

H10: the navio handpiece (part number 110137 / serial number(b)(6), used in treatment, was return for evaluation.The navio handpiece had an issue where the drill kept popping out of the back of the handpiece during to a procedure on (b)(6) 2018.The initial visual/functional investigation confirmed the reported event.The distance above the wave spring and down to the plunger holder was measured around the circumference of the snap lock.The maximum expected distance was not within specification for this dimension and therefore, the part does not conform to its design specifications.A device history record review found no conditions which could contribute to the reported event and the device met all specifications during release for distribution.A complaint history review found similar reports and this issue will continue to be monitored.The navio surgical system for unicondylar knee replacement and patellofemoral arthroplasty user's manual released at the time of the complaint provides no information regarding the dimensional discrepancies for the distance above the wave spring and down to the plunger holder.This failure is captured in the navio risk profile.The root cause of this issue was found to be due to supplier / raw material fault.The per complaint details, the device malfunctioned during use.Based on the information provided, as the user aborted the procedure and changed to manual instrumentation; there was no surgical delay or patient injury/impact reported.Therefore, no further medical assessment is warranted at this time.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9984321
• MDR Text Key: 188542361
• Report Number: 3010266064-2020-00699
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 09/04/2018
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 04/21/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention