MAUDE Adverse Event Report: ETHICON INC. GUT PL UD 18IN 4-0 S/A SC-1; SUTURE, ABSORBABLE, NATURAL

Catalog Number	1824H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2024 and suture was used.During an unknown procedure while suturing through pt's (patient's) nasal cartilage, surgeon realized that the needle had come off of the suture.Imaging and endoscopy were required to locate and remove the needle from right turbinate.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/5/2025.H6 component code: g07002 - device not returned.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, or its employees that the report constitutes an admission that the product, ethicon, 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 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: wj1824p30 is not a valid lot.Please provide the lot number.Additional information was requested, the following was obtained: was the needle piece(s) retrieved during the same procedure? yes what measures were taken to retrieve the broken piece? searched room with magnet and patient with visual inspection and imaging was there any additional tissue damage as a result of searching for the needle piece? no was the procedure completed without any adverse effect to the patient? yes what was the appearance of the needle during the removal? intact please provide the product code: ref (b)(4) please provide the lot number: lot #wj1824p30.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.D4: udi: as the catalog/model number was not provided, the (01) gtin is not available.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.User facility medwatch form #mw5163984.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 3/6/2025.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, or its employees that the report constitutes an admission that the product, ethicon, 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 information was requested, the following was obtained: 2.7.25 updated lot number- 102rl5.
Additional Manufacturer Narrative
Product complaint # (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.Corrected data: d3 mfr email.

• Brand Name: GUT PL UD 18IN 4-0 S/A SC-1
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21314115
• Report Number: 2210968-2025-01395
• Device Sequence Number: 8169458
• Product Code: GAL
• UDI-Device Identifier: 10705031002654
• UDI-Public: (01)10705031002654(17)290731(10)102RL5
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2025

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 Catalogue Number: 1824H
• Device Lot Number: 102RL5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 02/07/2025; 11/26/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/06/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2024
• 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 Age: 28 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White