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

Catalog Number	Z496G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used.During the procedure, the doctor reported that the wire was prone to breakage during suturing.(when the wire is not clamped with other instruments and the wire is pulled by hand) and it has happened many times, and finally i couldn't stand it before making this report.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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, 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.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.The manufacturing records could not be reviewed as the batch/lot number is unknown.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.¿ how many devices demonstrated the alleged deficiency? ¿ did the event occur during one or multiple patient procedures? ¿ what is the total number of procedures? ¿ have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? ¿ please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).Additional h11: pdsii clr 18in 4-0 s/a ps-2 prm mp (z496g) : unknown pdsii clr 18in 4-0 s/a ps-2 prm mp (z496g) : lot code/lot number: 102468 list of other j&j products (non-customer complaint products) used in the case surgery.***.Has there been a patient or user injury report? ## no *** are there any noticeable delays? ## unknown *** if available, provide the product order number (po).## ***.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.

• Brand Name: PDS
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON, INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25049331
• Report Number: 2210968-2026-04718
• Device Sequence Number: 10369729
• Product Code: NEW
• UDI-Device Identifier: 10705031061217
• UDI-Public: (01)10705031061217(17)290630(10)102468
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: N18331
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: Z496G
• Device Lot Number: 102468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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