MalfunctionHWC
4.5 CORTICAL LOCKING SCREW
Received Dec 29, 2006 · Event occurred Oct 5, 2006
Report 808206 · MDR key 808206
Device
Generic name
Surgical Hardware, Femur Screw
Manufacturer
Depuy Ace MedicalModel number
*Catalog number
14022-60/14022-56/14022-48
Lot number
UNK
Product problems
- Break
- Explanted
Patient
24 YR
- Pain
- Surgical procedure
Narrative
Description of Event or Problem
INITIAL SURGERY: INTERMEDULLARY NAIL RIGHT FEMUR. PATIENT RETURNED FOUR AND A HALF YEARS LATER WITH PAIN, IT WAS NOTED THAT THE LOCKING SCREWS TO THE NAIL HAD BROKEN. PATIENT UNDERWENT MINOR SURGERY TO REMOVE BROKEN SCREWS. PHYSICIAN STATED THAT THIS WAS RELATED TO NORMAL WEAR AND TEAR OVER A 4 1/2 YEAR PERIOD FOR AN ACTIVE YOUNG ADULT.