MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/90MM FOR 03.503.044
Received Jul 30, 2026 · Event occurred Jul 9, 2026
Report 8030965-2026-07842 · MDR key 50084331
Device
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that while performing the procedure on the middle third of the face, the first device broke upon insertion to create the opening, and the second device broke when creating the openings in the mandible. There was no reported patient or user harm. There was no significant delay.
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. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.