MAUDE Adverse Event Report: KERI MEDICAL SA KERIFLEX; FINGER PROSTHESIS

Model Number	210-P10020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All information reasonably known to the importer is included in this report.
Event or Problem Description
Implant broke less than 9 weeks post op.

• Brand Name: KERIFLEX
• Common Device Name: FINGER PROSTHESIS
• Manufacturer (Section D): KERI MEDICAL SA; chemin du pre-fleuri 5; geneva, plan-les-ouates 1228 ; SZ 1228
• MDR Report Key: 25548520
• Report Number: 3009540749-2026-00004
• Device Sequence Number: 16138998
• Product Code: KYJ
• UDI-Device Identifier: 07640181160600
• UDI-Public: 07640181160600
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2026
• Report Date (Section F): 06/18/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 210-P10020
• Device Lot Number: 059822003000
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/09/2026
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 06/18/2026