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

Model Number PFSR110137

Device Problem Mechanical Jam (2983)

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

Event Date 07/06/2020

Event Type  malfunction  

Event Description

It was reported that during a case, they kept receiving a handpiece jammed error before any bone was cut.The procedure was changed to manual instrumentation as a result and caused a delay of fewer than 30 minutes.The handpiece would not clear test so it is faulty.No other complications were reported.

Manufacturer Narrative

Results of investigation: the reported device (pn110137, sn (b)(6)), used in treatment, was returned for evaluation.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found similar reports, this issue will continue to be monitored.This failure mode is identified in the navio risk profile.The navio user's manual (500196) provides information for handpiece troubleshooting in the "common problems & solutions table" section.A relationship, if any, between the subject device and the reported event could be determined.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed and a cannot communicate with handpiece error was displayed before the test could start, so further testing could not be performed.No containment or corrective actions are recommended at this time.In addition, a visual inspection was performed on the part beyond the reported complaint.The strain relief on the handpiece side is pulling away from the collet and the connector outer body rim is misshaped.Care and caution should be exercised during the surgical site setup and tear down to protect the device cable and from sharp objects or from situations that pin the cable between two objects.Do not use excessive force on the device strain reliefs during the decontamination process to minimize separating the cable from the strain relief.Refer to the navio surgical system user's manual and the navio surgical system instrument kit cleaning and sterilization guide for proper handling.The medical investigation found that: this complaint from the united states reports the navio handpiece jammed error before any bone was cut.The procedure was changed to manual instrumentation as a result and caused a delay of fewer than 30 minutes.No other complications were reported.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.

• 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: 10348564
• MDR Text Key: 201367353
• Report Number: 3010266064-2020-01693
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• 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: 08/07/2020
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention