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

Catalog Number	PDP845G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a urethroplasty on (b)(6) 2026 and suture was used.During the procedure, after the initial verification of the required supplies and the normal start of the procedure, a quality failure associated with a suture occurred, whose needle was fractured during the placement of a urethral repair point, leaving a portion of it apparently retained in the surgical field.In view of the event, the surgeon performed a manual search and by enlargement of the dissection, complemented with fluoroscopy, radiography and ultrasound.Without initially being able to locate the fragment after more than an hour of searching, it was decided to continue with the surgery using mainly a different suture.Subsequently, when another suture was used again, deformation of the needle was evidenced during its passage, which reinforced the suspicion of a possible defect of the product.Finally, during a new surgical review, the assistant identified and removed the missing fragment of the needle, managing to complete the count of surgical material and confirm that no foreign body was retained in the patient's cavity.There is no sample of this product for analysis, as it was discarded.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.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.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.Please confirm: the needle on the first pds 4/0 broke and the needle of the second pds 4/0 suture that was deformed did not break? is this correct? please clarify what deformation of the second needle refers to.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.The diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? for the original intended closure, how were all layers closed? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? what instruments were used to grasp the needle? where was the needle grasped during use? what was the size of the broken needle fragment? where did the needle break (tip, middle, swage area)? please describe any medical/surgical intervention required for this suture event including dates and results.What is meant by ¿during a new surgical review, the assistant identified and removed the missing fragment of the needle¿? was the needle piece retrieved during the same procedure? was the needle piece retrieved during a second procedure/re-operation? were there any unexpected outcomes or complications as a result of the prolonged surgery time? was there any change in the patient¿s post-operative care due to the prolonged procedure? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name?.

• Brand Name: PDS PLUS
• 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: 50122498
• Report Number: 2210968-2026-07735
• Device Sequence Number: 17538924
• Product Code: NEW
• UDI-Device Identifier: 10705031048638
• UDI-Public: (01)10705031048638(17)271231(10)10D8XJ
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K212380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PDP845G
• Device Lot Number: 10D8XJ
• 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: 07/23/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male