MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH CMC 1; finger prosthesis

Catalog Number	NTO010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury

• Brand Name: TOUCH CMC 1
• 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: 50860376
• Report Number: 3009540749-2026-00011
• Device Sequence Number: 21209486
• Product Code: KYJ
• UDI-Device Identifier: 07640181160037
• UDI-Public: 07640181160037
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026
• Report Date (Section F): 09/22/2026

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 Catalogue Number: NTO010
• Device Lot Number: 9477
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/24/2026
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2026
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/22/2026