MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 27IN 2-0 SA CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B414
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested, and the following was received: -can you identify the lot number of the product that was used? --tmbbdx.-please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.--device shipped out today 7/24 shipper kit was delivered 7/23.H3 analysis: the product was returned to ethicon for evaluation.One detached needle and one suture outside its packaging were received for analysis.Product code sxmp1b414.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 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.
Event or Problem Description
It was reported that a patient underwent a total hip replacement on (b)(6) 2024 and suture was used.Prior to use, when they pulled the suture out of the packet the suture broke.Another device was used to complete the surgery.No adverse patient consequences were reported.Upon evaluation of the returned device, an incorrect swage defect was identified.Additional information was requested.

• Brand Name: SFXSPI MCL+ UNI UD 27IN 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20181447
• Report Number: 2210968-2024-09441
• Device Sequence Number: 8363790
• Product Code: GAM
• UDI-Device Identifier: 10705031236400
• UDI-Public: (01)10705031236400(17)251031(10)TMBBDX
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

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 Expiration Date: 10/31/2025
• Device Catalogue Number: SXMP1B414
• Device Lot Number: TMBBDX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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