MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH® - CMC1 PROSTHESIS; TOUCH® - CMC1 PROSTHESIS STRAIGHT NECK 0° - 10MM - L

Model Number	TOUCH® - CMC1 PROSTHESIS STRAIGHT NECK 0° - 10MM - L
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed since the affected device was returned for investigation.A review of the device history record for the reported lot did not indicate any abnormalities related to the reported event.After a thorough investigation (returned device, device history record review, medical imaging, complaint history review), it appears that the failure may be primarily related to an overstress or an oxidation due to patient metabolism, which led to an abnormal wear of the prosthesis.The identified root cause represents the most likely explanation based on current evidence and does not constitute definitive proof of causality.
Event or Problem Description
It was reported that after receiving a touch prosthesis on his left hand, the patient (a 65-year-old man) had received a touch prosthesis in his right hand in (b)(6) 2025.He returned for a check-up in (b)(6) 2025 and then presented with pain at the end of (b)(6) 2025.He underwent a revision surgery on (b)(6) 2025 with replacement of the neck (the pe liner was found to be perforated).

• Brand Name: TOUCH® - CMC1 PROSTHESIS
• Common Device Name: TOUCH® - CMC1 PROSTHESIS STRAIGHT NECK 0° - 10MM - L
• 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: 23726496
• Report Number: 3024706750-2025-00028
• Device Sequence Number: 21490131
• Product Code: SFA
• UDI-Device Identifier: 07640181160037
• UDI-Public: 07640181160037
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P240020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/28/2025

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
• Device Expiration Date: 05/01/2026
• Device Model Number: TOUCH® - CMC1 PROSTHESIS STRAIGHT NECK 0° - 10MM - L
• Device Catalogue Number: NTO010
• Device Lot Number: X5119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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: 65 YR
• Patient Sex: Male