MAUDE Adverse Event Report: ETHICON INC. ETHILON SUT 30IN(75CM) 4-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	F24022H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Additional information was requested and the following was obtained: customer reported that described issue happened several times in different procedures with sutures from this lot.Customer is unable to provide details about the other incidents, but is returning all material from affected lot.What was the initial procedure? unknown.What is the event day and procedure date? unknown.What is the lot number? qdbeeb.Could you please confirm how many devices present the issue (pull off suture needle)? pls see (b)(4).Did the 47 pieces returned present the issue (pull off suture needle)? customer is returning complete lot - (b)(4).Did the other issues was reported in other pc numbers? if yes could you please provide pc numbers? (b)(4).Customer is unable to provide details about other incidents.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2020 and suture was used.During the procedure, the suture got detached from the needle.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4) date sent to the fda: 2/5/2021 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 b5 event: it was reported that the needle separated from suture without using much force.The surgery was completed with a new suture.There was no delay in surgery.Additional h6 component code: g07002 - conforming device additional information: d9, h6 a manufacturing record evaluation was performed for the finished device batch qdbeeb, f24022h55 and no non-conformances were identified.Additional h3 investigation summary: it was reported that the needle separates from suture without using much force.Surgery completed with new suture.A sealed box (36 ea) and an opened sample with eleven unopened samples of product code f24022h, lot # qdbeeb were received for evaluation.During the visual inspection of thirteen unopened samples, no defects were found on the packages.The samples were opened, and swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects or damaged were observed.A functional test was performed and the pull force were 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.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.

• Brand Name: ETHILON SUT 30IN(75CM) 4-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11038159
• Report Number: 2210968-2020-10098
• Device Sequence Number: 1046462
• Product Code: GAR
• UDI-Device Identifier: 10705031238763
• UDI-Public: 10705031238763
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: 03/31/2025
• Device Model Number: F24022H
• Device Catalogue Number: F24022H
• Device Lot Number: QDBEEB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 02/05/2021
• Patient Sequence Number: 1