GLOBAL ICON
Received Jul 31, 2026 · Event occurred Jul 15, 2026
Report 1818910-2026-13078 · MDR key 50098108
Device
Product problems
- Device-Device Incompatibility
- Material Deformation
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that during a demonstration of the instruments it was observed that the icon Humeral punch bent and would not go through the icon Humeral prep guide. There was no surgical delay and no harm to the patient. All available information has been disclosed. No additional information could be provided.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (b)(4).This report is being submitted pursuant to the provisions of 21 CFR, Part 803 (and/or Part 4, as applicable). This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by DePuy Synthes, or its employees that the report constitutes an admission that the product, DePuy Synthes, or its employees caused or contributed to the potential event described in this report. H11: Additional Manufacturer Narrative:D4: UDI: As the lot number for the device involved in the event was not provided, the full UDI is currently not available.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.