8.5MM MEDULLARY REAMER HEAD
Received Jul 27, 2026 · Event occurred Jun 26, 2026
Report 8030965-2026-07543 · MDR key 50005804
Device
Product problems
- Break
- Entrapment of Device
Patient
Not reported
- Foreign Body In Patient
Narrative
Description of Event or Problem
It was reported that the IM Reamer head broke into four (4) pieces while reaming a femur. Surgeon could not collect all fragments so had to leave them in the patient. Event occurred during the procedure. Broken reamer head resulted in bending the tip of the reamer shaft.
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.