MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES ASSY, HNDPC EXT, CMPTR CRT, NAVIO; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 220013

Device Problem Intermittent Communication Failure (4038)

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

Event Date 09/18/2018

Event Type  Injury  

Event Description

It was reported that, during an ukr surgery, the system did not allow handpiece to "home".After switching out hand pieces and drill, as well as re-booting the system, the handpiece did not home.The case was cancelled as consequence.The patient outcome is unknown.The results of investigation indicate that there was a ff01 hall sensor error that might have been caused by the handpiece extension cable; nevertheless, this part worked as intended during evaluation; therefore, the problem could have been an intermittent connection between the handpiece connector and the receptacle.

Manufacturer Narrative

H10: the device, used in treatment, was returned for investigation.Log files and case screenshots were also returned.The initial visual/functional investigation found that: review of the log files shows there was an ff01 hall sensor error before and after the handpieces were swapped, indicating that it was more likely to be an issue with the handpiece extension cable than the handpieces.Inspection of the returned handpiece extension cable found that it did not have any recessed pins.It was connected to a system and two handpieces were run though characterization, retraction, homing, and exposure mode as expected and without any issues.Discussion with the service manager found that during a service visit, 3 of the handpieces at the account were tested using the returned cable and 3 were tested using the replacement extension cable.All worked as expected without issue.Device history record review found the device met the specifications at the date when it was released to distribution.A complaint history review for this issue found that this was the first occurrence of a homing failure with the handpiece extension cable.The surgical technique guide released at the time of the complaint provides instructions for using the handpiece.The "handpiece home position" contains information for performing homing and steps for failed homing attempts.This failure is an identified failure mode within the risk file.A relationship between the device and the reported event could not be established.No problem found with the extension cable.Per complaint details, the device malfunctioned and the procedure was aborted, as a result, the case was cancelled.Based on the information provided, there was no patient injury.However, the impact to the patient due to the cancellation of the procedure could not be concluded; therefore, no further medical assessment is warranted at this time.

• Brand Name: ASSY, HNDPC EXT, CMPTR CRT, NAVIO
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9995845
• MDR Text Key: 188836410
• Report Number: 3010266064-2020-00768
• 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: 08/27/2020

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?: No
• Device Operator: No Information
• Device Catalogue Number: 220013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR