EXPEDIUM
Received Jul 31, 2026 · Event occurred Jan 1, 2026
Report 1526439-2026-01137 · MDR key 50105672
Device
Generic name
Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Manufacturer
Depuy Spine IncCatalog number
310002155P
Product problems
- Break
Patient
Unknown
- Insufficient Information
Narrative
Description of Event or Problem
It was reported that instruments broke during a revision case with sclerotic bone. No further information is 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. Additional 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 MedWatch, a Follow-up MedWatch will be filed as appropriate.