OSTEOTOME
Received Jul 24, 2012
Report 1226348-2012-00356 · MDR key 2666776
Device
Generic name
Osteotome
Product problems
- Break
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- No Consequences Or Impact To Patient
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
MEDWATCH FORM REPORTED THAT A PIECE OF THE OSTEOTOME BROKE OFF WHEN IT HIT THE STAPLE. ADDITIONAL INFORMATION PROVIDED IN A PHONE CONVERSATION EXPLAINED THAT THE PRODUCT CODE IS NOT AVAILABLE. THE DEVICE WAS DISCARDED AND THERE WAS NO HARM, PHYSICAL OR OTHERWISE TO THE PATIENT AS THE BROKEN PIECE WAS VISUAL AND RETRIEVED. NO DELAY IN THE PROCEDURE WAS REPORTED.
Additional Manufacturer Narrative
IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. (B)(4): DEVICE WAS DISCARDED.