MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 3-0 S/A FS-1; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	663H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown skin closure procedure on an unknown date in 2021 and suture was used.During the procedure, the suture broke.Another like device was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).(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: did the "suture breakage" occur during use on the patient or during handling before use on the patient? during use in patient.Please clarify for each of the 4 involved devices.Were there any patient consequences? no.Was the procedure completed successfully? how? with new suture.Procedure name and date? unknown.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported in 2210968-2021-13000, 2210968-2021-13001 and 2210968-2021-13002.
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: did the "suture breakage" occur during use on the patient or during handling before use on the patient? during use in patient.Please clarify for each of the 4 involved devices.Were there any patient consequences? no.Was the procedure completed successfully? how? with new suture.Procedure name and date? unknown.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported in 2210968-2021-13000, 2210968-2021-13001 and 2210968-2021-13002.
Event or Problem Description
It was reported that a patient underwent an unknown skin closure procedure on an unknown date in 2021 and suture was used.During the procedure, the suture broke.Another like device was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 01/24/2022.H6 component code: g07002 - no device problem found.This report is being submitted pursuant to the provisions of 21 cfr, part 803.Part 4 subpart b.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 investigation summary: one opened box with three packets of product code 663h was returned for analysis with the packaging closed.Upon initial inspection to the samples no external damage was observed on the packets.In order to evaluate the conditions of the returned samples, the three packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to damaged or breakage sutures and no defects were observed during evaluation.Functional test was performed, and the tensile strength 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.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.The following information was requested, but unavailable: *for each case please confirm how many products experienced the quality issue and the lot number for each case: customer is unable to provide further details.

• Brand Name: ETHLN BLK 18IN 3-0 S/A FS-1
• 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: 13092961
• Report Number: 2210968-2021-13003
• Device Sequence Number: 11264602
• Product Code: GAR
• UDI-Device Identifier: 10705031007789
• UDI-Public: 10705031007789
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

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: 04/30/2026
• Device Model Number: 663H
• Device Catalogue Number: 663H
• Device Lot Number: REBASL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• 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