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

Catalog Number	Z334H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 following information was requested, but unavailable: -was surgery delayed due to the reported event? --> unknown, -was procedure successfully completed? --> unknown, -were fragments generated? --> unknown, -if yes, were they removed easily without additional intervention? --> unknown, -was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, -is the patient part of a clinical study --> unknown, additional information was requested, and the following was obtained: ¿ did this issue contribute to any patient adverse event? no ¿ were x-rays taken to locate the needle piece(s)? yes ¿ was there any additional tissue damage as a result of searching for the needle piece? no ¿ is there any plan in place to remove the needle piece in the future? no ¿ if yes, please provide the scheduled date.¿ what tissue structure the broken needle was located? suture was located at the coccyx level.¿ what is the surgeon's opinion of consequences to the patient? no long-term effects as a result of the retained needle tip.¿ what is current condition of the patient? no acute distress.¿ was mri performed? no.¿ can you identify the product code and lot number of the product involved? 0 pds ct2 ref: z334 lot: 10a8t1 ¿ it has been stated that the physician feels ¿she is not the only one this has happened to.¿ are you aware of any other instances where this has occurred? no if yes, please provide all available information so that we can open an additional product complaint for any additional issues.¿ how many devices demonstrated the alleged deficiency? n/a ¿ did the event occur during one or multiple patient procedures? n/a ¿ what is the total number of procedures? n/a ¿ have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? n/a 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.
Event or Problem Description
It was reported that a patient underwent a robotic procedure on (b)(6) 2026 and suture was used.During a robotic case; the doctor had a mishap a week ago with using an 0, suture, on a ct-2 needle which broke, and there is a 4 millimeter fragment inside the patient.Surgical delay is unknown.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: 25399904
• Report Number: 2210968-2026-06079
• Device Sequence Number: 13446466
• Product Code: NEW
• UDI-Device Identifier: 10705031060562
• UDI-Public: (01)10705031060562(17)300731(10)10A8T1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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: Z334H
• Device Lot Number: 10A8T1
• 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: 05/16/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2025
• 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