MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 18IN 2-0 SA CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B411
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 11/18/2024.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.Additional information was requested, the following was obtained: 1.Were there any patient consequences? 2.When the event occurred? 3.Please provide lot number.4.Please clarify how many devices was used on this single procedure if this event occurred in multiple procedures, please provide information requested above for each patient event.5.If this event occurred in multiple procedures, please create a product complaint for each event and provide the respective reference number(s).6.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.There were 2 suture breakages in two separate cases on the same afternoon of the 22nd october at renacres.The first patient was a tha in which the 2-0 spiral pds suture broke, sxpp1b411, lot tmbemk.The second patient was also a tha case, but this time it was a monocryl suture 3-0 sxmp1b103, lot uabbhl, that snapped.Complaint logged for second complaint under (b)(4).The following information was requested: during any of these two cases: * were there any patient consequences? * please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) * please perform and document the follow-up attempt for product return.Please document the shipment tracking number in the notes or rmao sections.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 a total hip arthroplasty procedure on (b)(6) 2024 and barbed suture was used.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.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.Additional information: h6, h4.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.

• Brand Name: SFXSPI PDS+ UNI VIO 18IN 2-0 SA CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• 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: 20711982
• Report Number: 2210968-2024-12157
• Device Sequence Number: 9638334
• Product Code: NEW
• UDI-Device Identifier: 10705031236141
• UDI-Public: (01)10705031236141(17)281231(10)TMBEMK
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K150670
• 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): 12/13/2024

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: SXPP1B411
• Device Lot Number: TMBEMK
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2023
• 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