MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FINGER JOINT IMPLANT W/ GROMMETS 4; PROSTHESIS, FINGER, POLYMER

Catalog Number	G4700004
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
Swanson flexspan finger joint implant broke.Original surgery went well.Patient was doing well postop, going to physical therapy, no trauma or accident happened to related finger.Patient started having pain, had a follow up x-ray and the broken implant was seen on x-ray.
Additional Manufacturer Narrative
Correction: b2 - outcomes attributed to ae, h6 (device, method & results) codes.The reported event could be confirmed based on inspection of returned product.The device inspection revealed that a visual inspection of returned device confirms that one of the stem is broken off.The fracture surface suggests a clean fracture suggesting sudden breakage.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Swanson flexspan finger joint implant broke.Original surgery went well.Patient was doing well postop, going to physical therapy, no trauma or accident happened to related finger.Patient started having pain, had a follow up x-ray and the broken implant was seen on x-ray.

• Brand Name: FINGER JOINT IMPLANT W/ GROMMETS 4
• 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: 22805328
• Report Number: 3010667733-2025-00945
• Device Sequence Number: 12999589
• Product Code: KWF
• UDI-Device Identifier: 00840420127532
• UDI-Public: (01)00840420127532(11)220823(17)300823(10)1740024
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: G4700004
• Device Lot Number: 1740024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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: Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female