MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES STRIDE INSERT SIZE B 8MM POLY TRIAL PN 100998; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 07/19/2014

Event Type  malfunction  

Event Description

It was reported that the poly trial was being removed from a cadaver by surgeon during a navio training lab and the corner of the poly broke off.The doctor was using forceps to remove the poly insert.Both pieces of the poly were recovered from the cadaveric knee and will be sent for evaluation.

Manufacturer Narrative

The reported device, intended for use for treatment, was returned for evaluation.Visual inspection of the returned device confirmed the trial poly cracked and broke in the thin section upon impacting into the tibial trial tray and that it was an older design.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 similar events.We were able to confirm there was a relationship established between the reported event and the device.The malfunction is likely due to the design of the poly trial.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.A factor that could have contributed to this issue is if the user impacted the poly trial causing the thin section to break.Poly trials are designed to drop into the tibial tray with no force.

• Brand Name: STRIDE INSERT SIZE B 8MM POLY TRIAL PN 100998
• 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: 9998632
• MDR Text Key: 189580683
• Report Number: 3010266064-2020-00163
• 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: 07/29/2020

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?: Yes
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1