MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 6IN 4-0 SA RB-1; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B434
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedue on (b)(6)2024 and suture was used.The problem of pulling off suture needle happened in surgery.Changed another one to complete the surgery.There is no report on patient's injury.The needle did not fell into the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # = > pc-(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.H6 component code: g07002 - pending results the following information was requested, but unavailable: - please provide lot number --unk.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/8/2024.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.H3 investigational summary: the product was returned to ethicon for evaluation.One empty labeled winding former, detached needle, and suture that belong to product code sxmp1b434 were returned.During the visual inspection of the sample, the swage and attachment area did not meet expectations.Since, the hit of the stake was higher than usual, causing that hit of the stake came across with the solid part of the needle.This condition caused the suture to be separated from the needle.Based on the information currently available, an incorrect swage defect was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: SFXSPI MCL+ UNI UD 6IN 4-0 SA RB-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.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19483883
• Report Number: 2210968-2024-05940
• Device Sequence Number: 12739008
• Product Code: GAM
• UDI-Device Identifier: 10705031236530
• UDI-Public: 10705031236530
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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: SXMP1B434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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