MAUDE Adverse Event Report: KERI MEDICAL SA TOUCH CMC 1 - OFFSET NECK PATTERN 6-S

Model Number	112-A51506
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a total joint arthroplasty using the touch cmc1 prosthesis, the trial neck fractured during removal; specifically, the head separated from the neck.The surgeon was using the forceps clamp from the instrument set intended for trial neck insertion and extraction.No impaction was involved.There were no adverse events or patient injuries associated with this occurrence.
Additional Manufacturer Narrative
A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.Manufacturing and inspection records confirmed the item had been released in accordance with specifications.After thorough investigation (dhr review, complaint history record), it appears that the defect is not attributable to a manufacturing or material issue but rather to external factors or usage conditions.Potential risks for instrument breakage and their root causes are listed in the labelling.No indications of manufacturing or design related problems were found during the investigation.No corrective actions are required at this time.

• Brand Name: TOUCH CMC 1 - OFFSET NECK PATTERN 6-S
• Common Device Name: OFFSET NECK PATTERN 6-S
• 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: 24496121
• Report Number: 3024706-2026-00016
• Device Sequence Number: 18812669
• Product Code: LXH
• UDI-Device Identifier: 07640181160839
• UDI-Public: 07640181160839
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: 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-A51506
• Device Catalogue Number: 112-A51506
• Device Lot Number: 8633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2025
• 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