MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 2-0 S/A PS PRM; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	585H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device 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.Event reported via 2210968-2021-12265, 2210968-2021-12266, 2210968-2021-12268, 2210968-2021-12270.
Event or Problem Description
It was reported that a patient underwent a wound closure procedure on (b)(6) 2021 and suture was used.During the procedure, the suture popped off the needle.No adverse patient consequences were reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/29/2021.H6 component code: g07002 no device problem detected.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: a sealed packet of product code 585 was returned to ethicon inc for analysis with the packaging closed.Upon initial inspection to the sample no external damages were observed on the packet.In order to evaluate the conditions of the returned samples, the packet was opened, and no defects were detected.The swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand to detect any issue on the suture and no defects were observed during evaluation.Functional test was performed, and the pull force result was above the minimum requirements.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.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.

• Brand Name: ETHLN BLK 18IN 2-0 S/A PS PRM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12916047
• Report Number: 2210968-2021-12267
• Device Sequence Number: 5718606
• Product Code: GAR
• UDI-Device Identifier: 10705031006393
• UDI-Public: 10705031006393
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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: 09/30/2025
• Device Model Number: 585H
• Device Catalogue Number: 585H
• Device Lot Number: QLBBMQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown