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

Catalog Number 110014

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/22/2014

Event Type  Injury  

Event Description

It was reported that while being used to insert the permanent poly implant, the white tip of the impactor broke.The broken piece was removed from the patient and the procedure was successfully completed.

Manufacturer Narrative

The device was used for treatment and was not made available to the designated complaint unit for investigation.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 (500007 revd) notes proper use of the device in the trial reduction section.We could not confirm if there was a relationship established between the reported event and the device.Visual inspection and functional evaluation could not be performed because the device was not returned.After reviewing the field report it was found that the device was disposed of and no part was returned.Therefore, a root cause could not be determined.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: TIBIAL POLY 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: 9994407
• MDR Text Key: 188809338
• Report Number: 3010266064-2020-00156
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 110014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention