OtherHTT
NORMED GEMERIC TRAUMA
Received Nov 24, 2014 · Event occurred Jan 22, 2014
Report 9613350-2014-04135 · MDR key 4290386
Device
Product problems
- Corroded
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN EASY EXPLANT BIT (DRILL BIT) SHOWED CORROSION. AS THE OCCURRENCE DATE OF THE EVENT IS UNK, THE MFR'S AWARENESS DATE WAS TAKEN AS OCCURRENCE DATE.
Additional Manufacturer Narrative
THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. ONCE MORE DETAILED INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED. (B)(4).