MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 18IN 3-0 SA PS PMP; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B111
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/28/2025.H6 component code: g07002 - no device problem found.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: * can you identify the lot number of the product that was used? * what is the procedure name and date? * please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) no further information available.Product shipped in.Procedure was orthopedic.H3 investigational summary: the product was returned to ethicon for evaluation.One used needle- suture piece outside its packaging was received for analysis.During visual inspection of the returned sample, the swage and attachment area were observed as expected; however, marks that appear to be caused by a surgical instrument were observed on the body needle.Also, a little suture piece was noted to be still attached to the barrel hole.Overall, no needle pull-off was observed.The functional test was not possible to perform according to suture.Length.The suture was examined, split suture and the extreme was noted to be cut probably caused by a surgical instrument.In addition, body fluids were noted along the strand.The other section of the suture was not returned for analysis.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used.It was reported that the needle came off suture.There were no patient consequence reported.Additional information was requested.

• Brand Name: SFXSPI MCL+ UNI UD 18IN 3-0 SA PS PMP
• 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21252120
• Report Number: 2210968-2025-01012
• Device Sequence Number: 8075417
• Product Code: GAM
• UDI-Device Identifier: 10705031236660
• UDI-Public: 10705031236660
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K151200
• 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
• Report Date (Section B): 01/28/2025

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: SXMP1B111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/28/2025
• 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