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

Catalog Number	NTO156
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent a revision due to dislocation.Brought the patient back for a revision operation.Exchanged short offset neck for a short straight neck.
Additional Manufacturer Narrative
All information reasonably known to the importer is included in this report.The complaint has been provided to the manufacturer (keri medical).

• 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: 50919838
• Report Number: 3009540749-2026-00012
• Device Sequence Number: 5753257
• Product Code: KYJ
• UDI-Device Identifier: 07640181160044
• UDI-Public: 07640181160044
• 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): 09/28/2026
• Report Date (Section F): 09/28/2026

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: NTO156
• Device Lot Number: 9550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/28/2026
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2026
• 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: 09/28/2026