MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES STRIDE FEMORAL INS/REM IMPACTOR HEAD; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number PFSR100931

Device Problem Material Fragmentation (1261)

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

Event Date 08/01/2016

Event Type  malfunction  

Event Description

It was reported that, during an ukr surgery, the femoral impactor broke in half while impacting.Another impactor was used to continue the case.The surgery was delayed for about 2 min.The patient was not harmed.

Manufacturer Narrative

H10 h3, h6: the device was used for treatment and was returned for investigation and was broken.Visual inspection was performed and found no defects were easily visible in the material.The attempt to replicate the issue with a new impactor head was unsuccessful.After 30 sterilization cycles the attempt to replicate the error was still unsuccessful.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 reports.The surgical system user's manual released at the time of the complaint (pn 500007 revg) provides instructions for using the femoral insertion/extraction tool.This is an identified failure mode within the risk assessment.We could confirm if there was a relationship established between the reported event and the device.The malfunction is most probably due to a mechanical component failure of the femoral impactor head breaking during use/impaction.

• Brand Name: STRIDE FEMORAL INS/REM IMPACTOR HEAD
• 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: 9997582
• MDR Text Key: 188891593
• Report Number: 3010266064-2020-00293
• 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: 08/11/2020

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: PFSR100931
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention