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

Catalog Number	SXPP1B410
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 5/1/2026.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: did any needle piece(s) fall into the patient? if yes, was\were the needle piece(s) retrieved during the same procedure? were x-rays taken to locate the needle piece(s)? what measures were taken to retrieve the broken piece(s)? was there any additional tissue damage as a result of searching for the needle piece(s)? please confirm below, how many devices demonstrated the reported alleged deficiency? product code sxpp1b410, lot#: 10a8dz.Product code sxpp1b410, lot#: 108d0p.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.Provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).No needle fell into the patient.Multiple of this suture code broke at the needle last week but they had just alerted me for the first time about it when i put in the complaint last week.Each lot listed in the complaint is used.I am unsure how much of each was used as the used product was discarded.The surgeon rotates between two or's.So, sending back two different lots (1 box each) each from a different or.They contain unused suture and i asked for replacements to be sent to the facility during this time.I am currently waiting on shipper kits to be sent to me so that i can ship off the product to be tested and assessed.The following information was received: they had a suture that broke multiple times this week.It is for multiple sutures now.We need a chipper kit and a replacement box sent o the facility.We have box with left over.Code sxpp1b410.I would like it sent asap.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used.It was reported by the sales rep that the surgeon of the facility has had an issue with the barbed suture breaking at the needle during usage.There was no patient consequence reported.Additional information was requested.

• Brand Name: STRATAFIX
• 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: 25056587
• Report Number: 2210968-2026-04754
• Device Sequence Number: 15987581
• Product Code: NEW
• UDI-Device Identifier: 10705031236134
• UDI-Public: (01)10705031236134(17)270430(10)108D0P
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: SXPP1B410
• Device Lot Number: 108D0P
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 05/08/2026; 05/24/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/18/2026; 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown