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 Consequences Or Impact To Patient (2199)

Event Date 10/18/2016

Event Type  malfunction  

Event Description

It was reported that the femoral impactor is split in two pieces.Since the allegation was noticed in the sterilisation center, no case was being carried out; therefore, no patient was involved at the time of the finding.

Manufacturer Narrative

H10 h3, h6: the device was intended for use in treatment.The device was not made available to the designated complaint unit for investigation.Thus, functional inspection could not be performed.A photo was returned for visual inspection, which confirmed that the femoral impactor head had broken into two pieces.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.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: 9997687
• MDR Text Key: 188895649
• Report Number: 3010266064-2020-00295
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR100931
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1