MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC SWANSON FINGER JOINT 2 W/O GROMMETS; PROSTHESIS, FINGER, POLYMER

Catalog Number	4700002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the physician had implanted a size 2 swanson flexible finger implant.The implant broke a day after the procedure.No additional information was available.
Event or Problem Description
It was reported that the physician had implanted a size 2 swanson flexible finger implant.The implant broke a day after the procedure.No additional information was available.
Additional Manufacturer Narrative
The complaint could not be confirmed, as the device was not returned for evaluation and no other evidence was provided.A review of the device history for the reported lot did not identify any abnormalities.No corrective actions are required at this time.A review of the labeling did not identify any abnormalities.No indications of material-related, manufacturing-related, or design-related issues were identified during the investigation.More detailed information regarding the complaint event is required in order to determine the root cause of the complaint event.If the device is returned or if additional information is provided, the investigation will be reassessed.

• Brand Name: SWANSON FINGER JOINT 2 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: 24094986
• Report Number: 3010667733-2026-00050
• Device Sequence Number: 16051485
• Product Code: KWF
• UDI-Device Identifier: 00840420121684
• UDI-Public: (01)00840420121684(11)250506(17)330506(10)1820664
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 4700002
• Device Lot Number: 1820664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2025
• 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
• Patient Sex: Unknown