MalfunctionGDG
JARIT BONE HOOK 9 SML 3/8
Received Apr 9, 2015 · Event occurred Mar 10, 2015
Report 2523190-2015-00019 · MDR key 4684147
Device
Product problems
- Bent
- Break
- Component Falling
Patient
80 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTS TIP WAS BENT OFF. ON (B)(6) 2015 CUSTOMER REPORTS THAT A TOTAL KNEE WAS BEING PREFORMED. THE TIP OF THE DEVICE WAS BENT AND BROKE OFF WHEN PULLING TRACTION ON THE TIBIA. THE TIP WAS RETRIEVED WITHOUT DIFFICULTY. NO PT HARM. ROUTINE POST OP X-RAY CONFIRMED NO PARTS LEFT IN THE PT.
Additional Manufacturer Narrative
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.