MalfunctionHTO
11-13MM STARTER/SIZER AWL
Received May 14, 2001
Report 2219689-2001-00069 · MDR key 333816
Device
Generic name
Implant
Manufacturer
Howmedica Osteonics Corp.Model number
NACatalog number
6266-5-311
Lot number
NA
Product problems
- Break
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE AWL WAS PLACED INTO FEMORAL CANAL AND BROKE AT SCORED SECTION OF AWL. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PATIENT OR DELAY IN SURGERY OR ANESTHESIA TIME.
Remedial action
- Other