MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ UNI UD 18IN 4-0 SA PS-2 PMP; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B118
Medical Device Problem Code	Break (1069)
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).H6 component code: g07002 - device evaluation pending.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 device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested, and the following was obtained via: unfortunately, we do not have a lot #.Tracking #s: (b)(4).Jlh is giving follow up answers.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.The manufacturing records could not be reviewed as the batch/lot number is unknown.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2025 and barbed suture was used.During the procedure, it was reported by the sales rep that during two cases, the item broke while suturing.Cases were completed with like product.No patient harm was reported.Product is available for return.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/8/2025.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: h3, h6.H3 investigational summary: the product was returned to ethicon for evaluation.One labeled winding former with a needle suture combination were received for analysis.During visual inspection of the sample, the swage and attachment area were noted to be as expected.Marks on the body needle appear to be by use of surgical instrument could be observed.The suture was examined, not body fluids along of strand were found.In addition, it was observed that the weld of first loop was detached.However, the loop possibly failure due to excessive force applied.As part of our quality process, the manufacturing records of this lots-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as on what caused the reported complaint.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Corrected information: h3 investigation summary.Additional information: d 4.Primary udi number.Corrected investigation summary = > the product was returned to ethicon for evaluation.One labeled winding former with a needle suture combination were received for analysis.The product code is sxmp1b118.During visual inspection of the sample, the swage and attachment area were noted to be as expected.Marks on the body needle appear to be by use of surgical instrument could be observed.The suture was examined, not body fluids along of strand were found.In addition, it was observed that the weld of first loop was detached.However, the loop possibly failure due to excessive force applied.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as on what caused the reported complaint.The instructions for use do contain the following caution: for the device to function properly, the stratafix¿ spiral pds¿ plus device must first be anchored in robust tissue using the fixation loop.Then subsequently engage the barbs into the tissue in a standard closure pattern.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.

• Brand Name: SFXSPI MCL+ UNI UD 18IN 4-0 SA PS-2 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
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22184169
• Report Number: 2210968-2025-06606
• Device Sequence Number: 8356156
• Product Code: GAM
• UDI-Device Identifier: 10705031236707
• UDI-Public: 10705031236707
• Combination Product (Y/N): Y
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2025

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: SXMP1B118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 07/08/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/08/2025; 07/11/2025
• 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