MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW NAVIO BONE PIN; STEROTAXIC INSTRUMENT, COMPUTER ASSISTED

Catalog Number UNKNOWN

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/09/2018

Event Type  Injury  

Event Description

It was reported that the patient experienced a periprosthetic fracture through the proximal femoral navio pin site 43 days post-operatively.The fracture was fixed using a distal femoral periloc plate.No further complications have been reported.

Manufacturer Narrative

H10: b4, g4, h2, h3, h6: updated information.H11: a1, b5, d1, d4, g3, g5: corrected information.

Event Description

It was reported that, 43 days after a navio-assisted tka surgery had been performed, the patient stumbled when walking and started feeling pain.The x-rays image show a periprosthetic fracture through proximal femoral navio pin site.The fracture was fixed with a distal femoral periloc plate.The patient outcome is unknown.

Manufacturer Narrative

H10, h3, h6: the reported device, used for treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.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 identified similar events.The navio surgical technique for tka (pn 500146 rev b) released at the time of the complaint provides instruction for proper bone pin placement in the bone tracking hardware section.This failure mode is an identied risk is the risk assessment.Factors that could have contributed to the reported event include drilling bone screws through the bone causing the bone to weaken (expected behavior), combined with the patient's fall, and the patient's age.A health hazard evaluation was opened for this issue.

• Brand Name: NAVIO BONE PIN
• Type of Device: STEROTAXIC INSTRUMENT, COMPUTER ASSISTED
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES, DIV OF SMITH AND NEPHEW; 2905 northwest blvd.; suite 40; plymouth MN 55441
• MDR Report Key: 7580564
• MDR Text Key: 110464853
• Report Number: 3010266064-2018-00007
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR