MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS STRAIGHT NECK 0° - 8MM - M

Model Number	NTO08
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	Joint Impingement (4834)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After a thorough investigation (returned device, dhr review, medical imaging and complaint history review), it appears the observed pe liner breakage is most likely attributable to excessive mechanical stress on the prosthesis, potentially related to over-tensioning associated with the initial neck size.The most probable root cause of this event is a surgical technique error.
Event or Problem Description
It was reported that a patient underwent total joint arthroplasty with a touch cmc1 prosthesis on (b)(6) 2025.In (b)(6) 2025, the patient noted a cracking or rupture-like sound accompanied by a minimal amount of bleeding.Subsequently, on (b)(6) 2026, the patient underwent a revision procedure during which the neck component was replaced.No trauma was reported in association with the event.

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS STRAIGHT NECK 0° - 8MM - M
• Manufacturer (Section D): KERI MEDICAL SA; chemin du pre-fleuri 5; plan-les-ouates, 1228 ; SZ 1228
• Manufacturer (Section G): KERI MEDICAL FRANCE; 34 rue antoine redier; archamps, 74160 ; FR 74160
• Manufacturer Contact: camille miletto ; chemin du pre-fleuri 5; plan-les-ouates, 1228 ; SZ 1228
• MDR Report Key: 24662925
• Report Number: 3024706750-2026-00017
• Device Sequence Number: 12025664
• Product Code: SFA
• UDI-Device Identifier: 07640181160020
• UDI-Public: 07640181160020
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P240020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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 Catalogue Number: NTO08
• Device Lot Number: X7799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male