MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXTRA & EXCEL POLYESTER SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	D7435
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: please clarify, the needle was broken or bend? 4 needles broke during this surgery.If the needle broken, please clarify, the piece retained in patient? if yes, how was it retrieved? broken parts could easily be located and were retrieved.How many devices were involved in this single procedure? 4 needles broke and/or bent.How the procedure was completed surgery was completed with new product.Was there any adverse consequence associated with the patient? no.Events reported in medwatch reports 2210968-2020-05008, 2210968-2020-05009, 2210968-2020-05010, and 2210968-2020-05011.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used on the skin.During the procedure, the needle broke.The broken parts could easily be located and were retrieved.Another like device was used.There were no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint #(b)(4) date sent to the fda: 07/24/2020 additional information: d4, d10, h4 h3 evaluation: representative samples returned to support investigation of multiple device issues captured in reports 2210968-2020-05008, 2210968-2020-05009, 2210968-2020-05010, and 2210968-2020-05011.Analysis results have been included in follow-up reports for each.Unopened samples of product were received for analysis.The complaint sample was not returned for evaluation.During the visual inspection of thirteen samples, no defects were found on the packages.The samples were opened, and the swage and attachment area of needles were noted to be as expected; also, the tip and body of the needles were examined under magnification and no defects, bend or needle breakage were found.Besides, the samples were tested by resistance test to needle and met the requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the samples conditions, no needle breakage was found.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10217842
• Report Number: 2210968-2020-05008
• Device Sequence Number: 13980144
• Product Code: GAT
• UDI-Device Identifier: 10705031027749
• UDI-Public: 10705031027749
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: D7435
• Device Catalogue Number: GE6664H
• Device Lot Number: JHH733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/24/2020
• Patient Sequence Number: 1