MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 2 S/A OS-4; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	X519H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number phh586, and no non-conformances related to the reported complaint condition were identified.Summary: a picture was received for evaluation.Upon to visual inspection of the picture, an overwrap packer of product code x519, lot # phh586 could be observed.No breakage sutures or sutures were noted in the picture.No conclusion could be reached as on what caused the reported complaint, since the sample was not returned for analysis.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.How many sutures were broken during tying in this single procedure? * what was the initial procedure? device return follow up.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent an unknown surgery on (b)(6) 2021 and the suture was used.It was reported that the sutures were broken during tying.There was no delay in surgery.There were no patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 2/23/2021.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Additional h6 component code: g07002 - conforming device.Additional h3 investigation summary: the product was returned to ethicon inc for evaluation.Visual inspection and functional test evaluation were conducted on the returned devices.Visual analysis of the returned samples revealed that the vcpb840d samples were returned with no apparent damage on the packages.The samples were opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no defects or damage or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.The device performed without any defect noted.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional information was requested and the following was obtained: how many sutures were broken during tying in this single procedure? 2 sutures were broken during op.What was the initial procedure? tkr case.Note: events reported via mw # 2210968-2021-00827, and 2210968-2021-01723.

• Brand Name: EB EXC GRN 30IN 2 S/A OS-4
• 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: 11255108
• Report Number: 2210968-2021-00827
• Device Sequence Number: 11400872
• Product Code: GAT
• UDI-Device Identifier: 10705031057418
• UDI-Public: 10705031057418
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 06/30/2024
• Device Model Number: X519H
• Device Catalogue Number: X519H
• Device Lot Number: PHH586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 02/23/2021
• Patient Sequence Number: 1