ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jun 26, 2009 · Event occurred May 28, 2009
Report 2210968-2009-00741 · MDR key 1407930
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
MB46G
Lot number
AKB097
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
UNK
- Wound Dehiscence
- Surgical procedure
Narrative
Description of Event or Problem
INTERNATIONAL CUSTOMER REPORTED THAT THE PATIENT PRESENTED WITH A SEPARATION OF THE BREAST BONE TWO DAYS FOLLOWING EMERGENCY THORACIC SURGERY. THE SURGEON REPORTS THAT THE SURGICAL KNOTS WERE UNTIED. THE SURGEON COMMENTED THAT THE KNOT TYING METHOD MAY HAVE BEEN INCORRECT DUE TO THE URGENCY OF THE SURGICAL PROCEDURE. THE PATIENT WAS RETURNED TO SURGERY FOR REPAIR USING THE SAME PRODUCT. THE EXACT NUMBER OF DEVICES INVOLVED IS NOT KNOWN.
Additional Manufacturer Narrative
CONCLUSION CODE: A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL FORM WILL BE SUBMITTED ACCORDINGLY.