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

Catalog Number PFSR110014

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 04/20/2015

Event Type  Injury  

Event Description

It was reported that the dr was impacting the tibial tray implant at the end of the case and as he hit the poly impactor with the mallet, the tip chipped off.The piece was removed from the field and the procedure was completed successfully.

Manufacturer Narrative

H10, h3, h6: the device was used for treatment.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history found similar reports, this issue will continue to be monitored.This failure mode is identified within the risk assessment.The surgical technique, manual instrumentation, and product specifications for the stride unicondylar knee system notes proper use of the device in the trial reduction section.A photo of the device was provided for visual inspection, which confirmed the broken tip on the tibia impactor.We could confirm if there was a relationship established between the reported event and the device.The breakage was due to mechanical component failure of the device.A factor that could have contributed to this issue is if the impactor tip was not able to withstand the impact stress applied by the user.

• Brand Name: STRIDE TIBIAL TRIAL IMPACTOR
• 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: 9984555
• MDR Text Key: 188472191
• Report Number: 3010266064-2020-00262
• 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: 04/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PFSR110014
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR