MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC SWANSON FINGER JOINT 0 W/O GROMMETS; PROSTHESIS, FINGER, POLYMER

Catalog Number	4700010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
It was reported that a wright medical finger joint implant fractured.Per intake discussion, the patient is scheduled for a follow-up surgery to address the implant failure.
Additional Manufacturer Narrative
This case is a duplicate of (b)(4), which captures the same patient, device, and event details.This record does not contain any additional information relevant to mdr reportability.This record does not contain any additional information relevant to mdr reportability.
Event or Problem Description
It was reported that a wright medical finger joint implant fractured.Per intake discussion, the patient is scheduled for a follow-up surgery to address the implant failure.

• Brand Name: SWANSON FINGER JOINT 0 W/O GROMMETS
• Common Device Name: PROSTHESIS, FINGER, POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23751088
• Report Number: 3010667733-2025-01475
• Device Sequence Number: 5854523
• Product Code: KWF
• UDI-Device Identifier: 00840420121691
• UDI-Public: 00840420121691
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 4700010
• Device Lot Number: 1763512
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female