ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

Additional Manufacturer Narrative

(B)(4). INCONCLUSIVE - THE INCRIMINATED SAMPLE RETURNED IS COMPOSED OF ONE PAPER FOLDER AND PART OF THE THREAD WAS STILL SWAGED TO A SMALL PART OF THE NEEDLE. THERE WERE NEEDLE HOLDER MARKS IN THE BREAKAGE AREA BUT THERE IS NO CLEAR DEFECT IDENTIFIED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. NO DEVICE FAILURE DETECTED AND THE PRODUCT IS WITHIN SPECIFICATION. THE NEEDLES WERE INSPECTED AND TESTED FOR STRENGTH. THERE WERE NO SIGNS OF MANUFACTURING OR MATERIAL DEFECTS FOUND.

Additional Manufacturer Narrative

(B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE INSIDE THE PATIENT. ONLY THE PIECE OF THE NEEDLE ATTACHED TO THE THREAD COULD BE RETRIEVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.