InjuryHTO
UNK FEMORAL REAMER
Received May 20, 2026 · Event occurred Apr 17, 2008
Report 0001822565-2026-01658 · MDR key 25237001
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Bone Fracture(s)
Narrative
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - EVENT OCCURRED IN CANADA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) ¿ DRILL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT DURING A HIP PROCEDURE, WHILE REAMING FOR THE FEMORAL STEM, A FEMORAL FRACTURE OCCURRED. REQUIRED PLACEMENT OF CERCLAGE WIRE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.