ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received May 4, 2012 · Event occurred Mar 7, 2012
Report 2210968-2012-01422 · MDR key 2559592
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
MX69G
Lot number
NI
Product problems
- Break
Patient
Not reported
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2012 AND SUTURE WAS USED. WHILE CLOSING THE ROTATOR CUFF THE TIP OF THE NEEDLE BROKE OFF INTO THE PATIENT. NO X-RAYS WERE PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Additional Manufacturer Narrative
(B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT (B)(4).
Additional Manufacturer Narrative
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