TRIALTIS
Received Jul 27, 2026 · Event occurred Jul 2, 2026
Report 1526439-2026-01071 · MDR key 50005100
Device
Product problems
- Material Deformation
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
Tap bent.No patient or user harm reported.No significant delay.Product has been discarded.
Additional Manufacturer Narrative
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. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D4: UDI: As the lot number for the device involved in the event was not provided, the full UDI is currently not available.