MAUDE Adverse Event Report: Ethicon Inc. PDS; Suture, Surgical, Absorbable

Catalog Number	PDP489G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
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.It was reported faulty sutures - snapping every time using pressure to utilize the suture itself.There were no surgical delays reported.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(6).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: did the reported issue contribute to any patient adverse consequences? no adverse event for patients how many devices demonstrated the alleged deficiency? multiple sutures failed my guess is about 10-12 across (b)(6) hospital, (b)(6) hospital and (b)(6) and now in my rooms.What is the total number of procedures? same number of procedures.Last year there was a period that there was a fault with the 6-0 pds as then snapped with little tension.After a while that was rectified and the 6-0 pds was back to normal.Again this year (currently) i have noticed some batches of pds are faulty and snap with little tension.I have noticed this in all the hospitals that i work at: (b)(6) hospital, (b)(6) and (b)(6) hospital and i have been asking the sutures to be sent back to you or replaced.I have also noticed this in the boxes of pds that have purchased for my private room.I have tried a couple of packets of the pds and both were the same.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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: 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 ; +1(303)552-6892
• MDR Report Key: 50914692
• Report Number: 2210968-2026-09745
• Device Sequence Number: 12111084
• Product Code: NEW
• UDI-Device Identifier: 10705031048393
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K212380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: PDP489G
• Device Lot Number: 106A8X
• 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: 09/20/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2025
• 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