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

Catalog Number	Z347H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
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.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.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.Additional h11: code: z347, lot: 1083da, exp: mar 2030 pds*ii violet monofilament 1 (4-0 metric) 36'' (90 cm) ct-1 36 mm 1/2c taper: ethicon endo surgery, side affected: not applicable, quantity affected: 1, quantity available to be returned: 0 list any j&j products that were utilized during the case but did not contribute to the reported event.Was there any reported patient or user harm? no.Was there a significant delay? no.If available, provide the product order number (po).Do you need product packaging to send the product back? no.Would you like a return label at the end of this process? no.
Event or Problem Description
It was reported that a patient underwent lap hysterectomy procedure on (b)(6) 2026 and suture was used.During the procedure, i was assisting during a laparoscopic hysterectomy, and while the surgeon was placing a laparoscopic suture to close the vaginal cuff, the suture broke.The surgeon did not apply any excessive tension to the suture.Everyone in the room was surprised by this.No adverse patient consequences were reported.Additional information was requested.

• 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.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24862911
• Report Number: 2210968-2026-03883
• Device Sequence Number: 10493147
• Product Code: NEW
• UDI-Device Identifier: 10705031060685
• UDI-Public: (01)10705031060685(17)300331(10)1083DA
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 04/13/2026

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: Z347H
• Device Lot Number: 1083DA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2025
• 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