MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE SCREW DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	NAVIO BONE SCREW DRIVER
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tka procedure, the adapter can no longer fix the navio bone screw drivers.They were worn out.They were swapped for their backups to continue the procedure with a delay of less than 30 minutes.No other complications were reported.
Additional Manufacturer Narrative
Additional info: d4, d9, g3, g6, g8, h2, h3, h4, h6, h10.Correction: g1.Results of investigation: the device, used in treatment, was returned for investigation.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.There were no indications of an issue that would potentially lead to a future performance issue.A complaint history review found similar reports, this issue will continue to be monitored.We were able to confirm if there was a relationship established between the reported event and the device.Visual and functional evaluation found that the pin driver failed to turn/rotate the bone pin because the inner driver is no longer attached to the pin driver.The malfunction was caused by mechanical component failure.A corrective action has been requested regarding this issue.

• Brand Name: NAVIO BONE SCREW DRIVER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10257715
• Report Number: 3010266064-2020-01646
• Device Sequence Number: 3083841
• Product Code: OLO
• UDI-Device Identifier: 00885556628904
• UDI-Public: 00885556628904
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NAVIO BONE SCREW DRIVER
• Device Catalogue Number: PFSR110164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Distributor Facility Aware Date: 04/23/2020
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1