MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z340H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
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.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 provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date of index surgical procedure? the diagnosis and indication for the index surgical procedure? 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)? how was the suture placed (interrupted or continuous)? how was the suture tied (square knot or multiple knots one end)? what tissue dehisced? onset date/time of dehiscence? (# post op days).How was the dehiscence managed? please describe any surgical intervention required for the wound dehiscence including date and findings.Please describe the appearance of the suture during the second procedure.Did the suture break post-op? if yes, please describe there on the suture the break was noted.Were there any precipitating patient stress factors for the sutures untying, breakage or pulling out of the tissue? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and 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? will product be returned? if so, please provide the return date and tracking information.
Event or Problem Description
It was reported that a patient underwent an vaginal cuff repair on an unknown date and suture was used.No changes were made to the surgical technique.Post-op, the patient experienced a dehiscence, requiring the patient to return to the operating room.The device is not available for return.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 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.Additional information: a3a, a4, b3, h4.Corrected information: h6 - type of investigation.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.Additional information was requested, and the following was obtained: 1.Unable to determine which lot number was used between the 2 lot numbers provided.2.Surgical date- (b)(6) 2025, see section a for demographic information.3.Diagnosis- heavy menses, fainting with menses, uterine prolapse.4.Total laparoscopic hysterectomy.5.Tissue used on- vaginal cuff.6.Normal tissue condition.7.Suture placed-interrupted.8.Suture tied-square knots.9.What tissue dehisced- vaginal apex dehisced.10.Date of dehiscence- (b)(6) 2025.11.Dehiscence managed- returned to or.12.Surgical intervention- completed an exploratory laparotomy to close the vagina.13.Appearance of the suture during the second procedure- unable to answer.14.Did the suture break post-op? if yes, please describe there on the suture the break was noted.No.15.Were there any precipitating patient stress factors for the sutures untying, breakage or pulling out of the tissue? none.16.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? none.17.Other relevant patient history/concomitant medications? none.18.What is the physician¿s opinion as to the etiology of or contributing factors to this event? none that is why we are concerned.19.What is the patient's current status? doing well.20.Product returned- no.

• Brand Name: PDSII VIO 27IN 0 S/A CT-1
• 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: 24144199
• Report Number: 2210968-2026-00817
• Device Sequence Number: 9210347
• Product Code: NEW
• UDI-Device Identifier: 10705031060623
• UDI-Public: (01)10705031060623(17)300731(10)10AMZG
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: Z340H
• Device Lot Number: 10AMZG
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 87 KG