MAUDE Adverse Event Report: ETHICON INC. ETHILON SUT 18IN(45CM) 4-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	1162H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a hand procedure on (b)(6) 2022 and suture was used.During the procedure, it was reported that all the needles of the box are standing out when the surgeon wants to use it.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).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.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 events.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.Please kindly confirm how many sutures that had needle pull off issue during the surgery? additional information was requested, and the following was obtained via: for the number of needles, it is the answer of my client¿ i agree that 19 needles is a huge number, but i have not the possibility to verify.For the lot number, it is: sabaup.I sent the rest of the box last week to wilmergen for the 1st question.I sent an email on monday, but the customer didn¿t answer yet.She explained to me that the event took place during the surgery, when the surgeon used it to pass the needle in the tissue.Events reported via: 2210968-2022-09070.
Additional Manufacturer Narrative
(b)(4).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.H3 analysis summary: the product was returned to ethicon for evaluation.Visual inspection and functional test evaluation were conducted on the returned devices.Visual analysis of the returned sample determined that it was received one open box with seventeen unopened samples that pertain to the product code 1162h.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets 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 no anomalies were observed during the evaluation.A functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Related events captured via 2210968-2022-09070.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/30/2022.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following additional information was received: as per the complaint, 19 sutures are involved.This indicates that 19 sutures pulled off in one surgery.Is it true? ->for the number of needles, it is the answer of my client¿ i agree that 19needles is a huge number, but i have not the possibility to verify.->for the lot number, it is: sabaup.Each needle comes off the thread when the surgeon uses the thread.The surgeon is dr cuenod different patients are concerned by this issue (but i don¿t know how many of them) the issue taked place when the surgeon hold the suture with an instrument or when he wanted to pass in a tissue.With all the sutures of the box (b)(4) & (b)(4) concern the same issue.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: ETHILON SUT 18IN(45CM) 4-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• 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 ; 9083863534
• MDR Report Key: 15719248
• Report Number: 2210968-2022-09069
• Device Sequence Number: 2919718
• Product Code: GAR
• UDI-Device Identifier: 10705031239456
• UDI-Public: 10705031239456
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2022

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 Model Number: 1162H
• Device Catalogue Number: 1162H
• Device Lot Number: SABAUP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2022
• Supplement Date Received by Manufacturer: 11/03/2022; 12/05/2022
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 11/30/2022; 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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