MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SUTURE; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B119
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.Attempts have been made to retrieve the device.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.Additional information was requested, and the following was obtained: please elaborate on the quality issue experienced with the product: please clarify what do you mean by the loop was damaged when the product was used""? the loop part of the suture was broken during use.Lot number of (b)(4): unk updated to 109zpu, 10a680.The customer requested to measure the strength of the loop.D4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.Additional information: d4 - the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch 109zpu mfg date: unk exp date: unk batch 10a680 mfg date: unk exp date: unk.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please confirm: the quantity involved in this complaint is 1? is this correct? lot numbers 109zpu and 10a680 are both possible lot numbers?.
Event or Problem Description
It was reported that a patient underwent an unknown cardiovascular procedure on (b)(6) 2026 and a barbed suture was used.During the procedure, the loop was damaged when the product was used.Another product was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.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, d9, h3 h3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that one unopened sample was received for analysis.Product code sxpp1b119.In order to evaluate the condition of the returned sample, the packet was opened.The swage and attachment area was noted to be as expected.The suture was dispensed without problems and examined, the loop was noted conforming to the visual standard.No anomalies or defects were observed.As part of eth quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device batch 109zpu, sxpp1b119-14 and no non-conformances were identified."a manufacturing record evaluation was performed for the finished device batch 10a680, sxpp1b427-15 and no non-conformances were identified.Additional information was requested, and the following was obtained via: the quantity involved in this complaint is 1? is this correct?=>yes.Lot numbers 109zpu and 10a680 are both possible lot numbers?=>maybe 109zpu.

• Brand Name: STRATAFIX SUTURE
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24756358
• Report Number: 2210968-2026-03353
• Device Sequence Number: 15630186
• Product Code: NEW
• UDI-Device Identifier: 10705031240889
• UDI-Public: 10705031240889
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K182873
• 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): 04/28/2026

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: SXPP1B119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/28/2026
• 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