MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES TRIAL - POLY; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 04/16/2018

Event Type  malfunction  

Event Description

It was reported tha during trailing, the surgeon was impacting the tibial trial and fractured the tibial plateau.He had prepped the lug holes, but not the keel.The surgeon placed a plate and several screws into the anterior medial tibial face.

Manufacturer Narrative

H10: the device, used in treatment, was not made available for investigation.There was no malfunction of the device as the reported event was due to a procedural error by the surgeon (user error).There was no part/serial/lot number provided for device history record review so it could not be concluded if the device met the manufacturing specifications.Nevertheless based on the description of the event, there is no indication of a product failure that could contribute to the reported complications the patient experienced during the surgery assisted with navio system.A complaint history review found similar reports to this event, the issue will continue to be monitored.Per the "navio surgical technique for use with the stride unicondylar knee system", figure 58 recommends the use of the keel punch tool to prep the keel and also notes ".For best accuracy results with the tibial component, it is recommended that the keel be cut out prior to placing the tibial trial component, using a 2 mm spherical bur in manual control mode." in this manual the user is given two options for keel prep (keel punch or 2 mm bur).The field report details note that the surgeon prepped the "lug holes" (aka post holes) on the tibia but did not prep the keel before impacting the tibial trial into the patient's tibia, which is not recommended by the surgical technique.Based on the information provided, we can confirm that there was not a relationship between the reported event and the device as there was no malfunction of the device.This is an identified failure mode within the risk assessment.Per complaint details, currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Based on the information provided, the patient impact beyond the reported tibial plateau fracture (likely due to the lack of keel prep prior to trialing), subsequent plating/modified procedure, and increased risk for post-op complications could not be determined.No further medical assessment is warranted at this time.

• Brand Name: TRIAL - POLY
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9998978
• MDR Text Key: 189311841
• Report Number: 3010266064-2020-00927
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K123380
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 64