MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ BI UD 6IN2 3-0 DA RB-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP2B402
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/12/2025.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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information was requested; the following was obtained: ¿ did the reported alleged deficiency occur over the same patient procedure? *if yes, - when did the alleged deficiency occurred (removal from package/ during handling prior to use on patient/ during passage through tissue/ during tying/ post-op)? if other, please explain.- how many devices demonstrated the alleged deficiency for each patient event? - please provide the product code and lot number.- were there patient consequences? if yes, please explain.*if it occurred in multiple procedures, - please confirm the number of patients affected by the alleged deficiency.- have any of these events been previously reported to ethicon? if yes, provide the respective reference number(s).- please create a new pc file for each patient/event.Please provide an answer for each patient-event: - when did the alleged deficiency occurred (removal from package/ during handling prior to use on patient/ during passage through tissue/ during tying/ post-op)? if other, please explain.- how many devices demonstrated the alleged deficiency? - please provide the product code and lot number.- were there patient consequences? if yes, please explain.Response: the matter has been resolved my colleague mo and manager candice went and saw mr moon.File reviewed.Lot unavailable.No device will be returned.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and barbed suture was used.It was reported that a suture broke.There were no patient consequences.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 7/10/2025.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.Additional information was requested, the following was obtained: yes.The matter has been resolved my colleague (b)(6) and manager (b)(6) went and saw mr (b)(6).

• Brand Name: SFXSPI MCL+ BI UD 6IN2 3-0 DA RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22196784
• Report Number: 2210968-2025-06730
• Device Sequence Number: 9275059
• Product Code: GAM
• UDI-Device Identifier: 10705031464421
• UDI-Public: 10705031464421
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K192580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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: SXMP2B402
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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