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

Catalog Number PFSR101100

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2016

Event Type  malfunction  

Event Description

It was reported that sales rep had two sets of stride trial trays sent in for two cases and both sets had tibial sizers that contained peg holes too small for the pegs to fit.The trays were sent back to charlotte with the unused implants following the cases.Procedure completed with set of back-up that was available.

Manufacturer Narrative

The device was used intended to be used during treatment and was not returned for evaluation.Thus, visual and functional inspection could not be performed.Dhr review found that no conditions which could contribute to the reported event were identified.This information reasonably suggests that the device met the specifications at the date when it was released for distribution.A complaint history review found similar complaints of the reported issue.The relationship of the device and the reported event has been established.Evaluation of these part numbers was completed.The drawings of the pegs and sizers were reviewed.The peg sizes are designed too large for the sizers.The prints were updated with the appropriate peg size and the lots for the old revisions in inventory were scrapped.The root cause of this issue is design - fit.

• Brand Name: STRIDE MANUAL INSTRUMENTS TRAY
• 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: 9989203
• MDR Text Key: 188651593
• Report Number: 3010266064-2020-00355
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR101100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1