MAUDE Adverse Event Report: ETHICON INC. SFXSYM PDS+ UNI VIO 24IN 1 SA CTX; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A445
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.No lot number available, they could not find the packaging.Hh (please refer to the attached email) ¿ pa manager i have the product in my possession available for return.Please send the return packing to my home address.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.
Event or Problem Description
It was reported a patient underwent a total knee arthroplasty procedure on (b)(6) 2026 and suture was used.The physician assistant made three to four passes with the suture for the first layer.On the subsequent pass the suture split/frayed at the junction where the needle connects to the suture appearing to separate at the needle suture interface no patient consequences.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: h 3.Device evaluated by manufacturer? additional information: h 3.Device evaluated by manufacturer?, h 6.Type of investigation, h 6.Type of investigation, h 6.Investigation conclusions.Investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that one needle suture in two sections was received for analysis.Product code sxpp1a445.During visual inspection of the needle.Marks were noted at the edge of the swage area.The barrel hole was examined, and a suture piece was still attached to the needle.The suture was examined, and the end of the suture was noted to be split and cut probably caused by a surgical instrument.In addition, body fluids and crimping marks were found in one suture piece.Since the sample was received open, the functional test could not be performed due to undetermined exposure time to the environment.To prevent this kind of damage: care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of surgical instruments, such as needle holders and forceps.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.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: SFXSYM PDS+ UNI VIO 24IN 1 SA CTX
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24445642
• Report Number: 2210968-2026-02011
• Device Sequence Number: 10443678
• Product Code: NEW
• UDI-Device Identifier: 10705031245273
• UDI-Public: 10705031245273
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: SXPP1A445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/23/2026
• 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