MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 18IN 2-0 SA CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B413
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/25/2024.H6 component code: g07002 - device not returned.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, 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: it was reported that "¿in the same day for 3 patients 4 suture needles came away from the thread." (b)(4) will capture event of patient 1.(b)(4) will capture event of patient 2.(b)(4) will capture event of patient 3.Please provide information requested below for each patient/event patient consequences? if yes, please specify.What was being done when the needle pulled-off (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? did the needle fall into the patient? if so, please provide the following information: were x-rays taken to locate the needle? was the needle piece removed from the patient during the same procedure? c.Does the needle remain in the patient¿s tissue? d."what tissue structure is it located? size of the needle retained e.Are any plans in place to remove the needle piece in future?" if retained, what is the surgeon's opinion of consequences to the patient? how many devices demonstrated the alleged deficiency? name of the procedure? provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).The following information was received: lot number: ucbbha, date of incident: (b)(6) 2024.What is the current location of the device? discarded.Facility information: (b)(6), healthcare professional: (b)(6) (b)(6).Remedial actions taken by healthcare facility, patient, or user subsequent to the incident: reported photo taken.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2024 and barbed suture was used.In the same day for 3 patients 4 suture needles came away from the thread.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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, 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.Corrected information: d2a.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

• Brand Name: SFXSPI MCL+ UNI UD 18IN 2-0 SA CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• 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 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20774797
• Report Number: 2210968-2024-12429
• Device Sequence Number: 8182167
• Product Code: GAM
• UDI-Device Identifier: 10705031236417
• UDI-Public: (01)10705031236417(17)260228(10)UCBBHA
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: SXMP1B413
• Device Lot Number: UCBBHA
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2024
• 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 Sex: Unknown