MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH CMC1 STEM HOLDER

Model Number	112-A32000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
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 (evaluation of the returned instrument, review of the device history record, and an assessment of relevant complaint history), it was determined that the most likely root cause for this event is the normal wear of the reusable instrument, which has been subjected to a high number of reprocessing cycles.
Event or Problem Description
It was reported that during a total joint arthroplasty of touch cmc1 prosthesis, the stem holder broke into two components during impaction, with one component remaining stuck within the final stem.Another instrument was subsequently used to implant a replacement stem.

• Brand Name: TOUCH CMC1 STEM HOLDER
• Common Device Name: TOUCH CMC1 STEM HOLDER
• 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 ; chemin du pre-fleuri 5; plan-les-ouates, 1228
• MDR Report Key: 24471156
• Report Number: 3024706750-2026-00015
• Device Sequence Number: 15848387
• Product Code: SFA
• UDI-Device Identifier: 07640181160914
• UDI-Public: 07640181160914
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P240020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 112-A32000
• Device Catalogue Number: 112-A32000
• Device Lot Number: P2767920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown