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

Catalog Number 110014

Device Problem Material Fragmentation (1261)

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

Event Date 02/23/2015

Event Type  malfunction  

Event Description

It was reported that while the dr was using the poly impactor to impact the final poly into the tibial baseplate, the poly end snapped into two pieces at the tip of the impactor.

Manufacturer Narrative

H10 h3, h6: the device was used for treatment and the tip of the poly impactor snapped off.The device was not made available to the designated complaint unit 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 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.We could not confirm if there was a relationship established between the reported event and the device.Photos of the device were not provided for evaluation and the device was not returned.Therefore, the root cause could not be determined.Factors that could have contributed to the event include mechanical component failure or the impactor not being able to withstand the impact stress applied by the surgeon.The tibial impactor design has since been updated to increase stiffness.

• 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: 9994084
• MDR Text Key: 190179068
• Report Number: 3010266064-2020-00260
• 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
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

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: 110014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1