inforMED
MalfunctionKWF

SWANSON FINGER JOINT 2 W/O GROMMETS

Received Jan 16, 2026 · Event occurred Dec 16, 2025

Report 3010667733-2026-00050 · MDR key 24094986

Device

Generic name

Prosthesis, Finger, Polymer

Catalog number

4700002

Lot number

1820664

Product problems

  • Fracture

Patient

NA · Unknown

  • Insufficient Information

Narrative

Additional Manufacturer Narrative

ONCE THE INVESTIGATION IS COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

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.

Description of Event or Problem

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.