MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® CMC 1; FINGER PROSTHESIS

Model Number	NTO08
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All information reasonably known by the importer is included in this report.
Event or Problem Description
Pt returned for 2 week post-op visit and was dislocated.Dr (b)(6) stated that he felt like the original neck (08) was too tight and caused a volar dislocation.Pt taken back to surgery on (b)(6).Original neck (nto08) was replaced with a (nto06).

• 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: 25733794
• Report Number: 3009540749-2026-00005
• Device Sequence Number: 13351887
• Product Code: KYJ
• UDI-Device Identifier: 07640181160020
• UDI-Public: 07640181160020
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2026
• Report Date (Section F): 07/07/2026

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: NTO08
• Device Lot Number: 9359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/18/2026
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/07/2026