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

Model Number NPFS02000

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2019

Event Type  malfunction  

Event Description

It was reported that before burring, a handpiece error warning came up and it was required to recalibrate the handpiece.Upon recalibration, the handpiece was giving the error 3 more times.And when trying to recalibrate the handpiece, error kept showing that the handpiece was not connected.Case was completed with same handpiece.No injuries involved and delay of less than 30min was reported.

Manufacturer Narrative

The navio handpiece, used in treatment, was returned for further evaluation and a visual and functional inspection was performed, which confirmed the reported event.Visual inspection did not find any rips or tears in the cable of the handpiece, especially at the handpiece end by the strain relief.The strain relief was attached to the handpiece and not pulled away.There were no bent or damaged pins in the connector.The exterior condition shows¿moderate wear (scratches, discoloration).It was noted that the snap lock is the older style without a pin.During functional evaluation, the handpiece was connected to a system and originally connected without issue.A case was created and at the ¿handpiece connection¿ screen, the cable was bent so that it showed as disconnected.A review of the log files on the system showed an over-current error.Over-current errors indicate that the internal wiring at the handpiece end has come apart in the cable, causing a short in the wiring and an over-current error.A device history record review found no conditions which could contribute to the reported event and the device met all manufacturing specifications during the release for distribution.A complaint history review found similar reports and this issue will continue to be monitored.The root cause was found to be an electrical component failure.These results are indicative of a known issue and corrective action has been requested for this issue.

• 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: 9999452
• MDR Text Key: 189165317
• Report Number: 3010266064-2020-01444
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628416
• UDI-Public: 00885556628416
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NPFS02000
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR