InjuryGAS
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Aug 3, 2012 · Event occurred Jul 9, 2012
Report 2210968-2012-03540 · MDR key 2681464
Device
Generic name
Suture, Nonabsorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
X31047
Lot number
DK6730
Product problems
- Break
Patient
57 YR
- Surgical procedure, additional
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2012 AND SUTURE WAS USED. THE NEEDLE TIP BROKE OFF AND GOT LOST IN THE TISSUE. THE SURGEON WAS ABLE TO SUCCESSFULLY RETRIEVE THE BROKEN NEEDLE FRAGMENT, BUT THE DISSECTION WAS EXTREMELY DIFFICULT. CURRENTLY, THE PATIENT IS WELL.
Additional Manufacturer Narrative
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Remedial action
- Other