MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. FUSEFORCE; STAPLE, FIXATION, BONE

Model Number FFNS1212

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Date 04/16/2020

Event Type  Injury  

Manufacturer Narrative

The products were not returned for evaluation nor were any images provided; therefore, product analysis cannot be performed.

Event Description

It was reported that the patient underwent a surgical procedure and sometime post-op the patient needed a revision due to an infected non-union site.

Manufacturer Narrative

H6: the products were not returned for evaluation.Preop, postop, and post revision radiographic images were provided for evaluation.Review of the preop image finds the right hallux is pointed inwards at the interphalangeal joint.The immediate index surgery postop image shows the hallux interphalangeal joint has been realigned with a headed screw and a staple is also visible.The post revision surgery confirms the screw and staple have been removed.The alignment appears to have been maintained.

Event Description

It was reported that the patient underwent a surgical procedure and sometime post-op the patient needed a revision due to an infected non-union site.

• Brand Name: FUSEFORCE
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• MDR Report Key: 11340385
• MDR Text Key: 232334404
• Report Number: 1043534-2021-00025
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K124045
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FFNS1212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 127