MalfunctionGDG
JARIT BONE HOOK 9 SML 3/8
Received Dec 24, 2014 · Event occurred Oct 7, 2014
Report 2523190-2014-00071 · MDR key 4380120
Device
Product problems
- Break
Patient
60 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER INITIALLY REPORTS TIP BROKE OFF. ON (B)(6) 2014 CUSTOMER REPORTS THAT THE DEVICE TIP BROKE OFF DURING A TOTAL KNEE REPLACEMENT WHILE ELEVATING A BONE. TIP WAS EASILY REMOVED, NO HARM DONE. ROUTINE POST OPERATIVE X-RAY CONFIRMS NO PARTS LEFT IN PT.
Additional Manufacturer Narrative
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.