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

Catalog Number 100039

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 05/23/2014

Event Type  Injury  

Event Description

It was reported that surgeon had difficult getting the d8mm poly into a size 7 tibial base plate.He used the poly impactor and just a mallet to and get it in, which is when the poly broke.He knows that the poly is designed to snap in on its own, but he could not get it without the help of an impactor so had no choice.It broke at the very end and he was still able to use it, so it did not affect the case.

Manufacturer Narrative

H10 h3, h6: the reported device, intended for use for treatment, was returned for evaluation but discarded.Visual inspection of the returned device confirmed the trial poly cracked and broke in the thin section upon impacting into the tibial trial tray.There was no part/serial/lot number provided for dhr review so it could not be concluded if the device met the manufacturing specifications.A complaint history review identified a prior similar event.The naviopfs¿ system for unicondylar knee replacement released at the time of the complaint provides detailed instructions for placement and removal of the poly trial.The user is instructed to follow the tibia first: implant planning and placement guidelines when going through this process.The poly insert trial is designed to engage with the tibial trial when placed in the patient's anatomy and prevents any catching from respective geometries.The user's manual provides detailed instructions for placing the poly trial.We were able to confirm there was a relationship established between the reported event and the device.The malfunction is likely due to the user impacting the poly trial causing the thin section to break.Poly trials are designed to drop into the tibial tray with no force.Subsequent changes to improve the design included removing snap features and adding a chamber to allow the trials to be inserted easily into the tibial trays by hand to make the poly trial stronger and more able to withstand impact.

• Brand Name: STRIDE INSERT
• 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: 9994420
• MDR Text Key: 188804168
• Report Number: 3010266064-2020-00161
• 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: 08/07/2020

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100039
• 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 Outcome(s): Hospitalization; Required Intervention