MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUTURE 30"(75CM) 5-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP148H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Attempts have been made to retrieve the device.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.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.A manufacturing record evaluation was performed for the finished device 106th4 / pdp148h batch number, 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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used.The suture was broken when the surgeon attempted to sew the tissue.The customer feedback said that the suture broke easily when it was pulled.Changed another one to complete the surgery.No adverse patient consequences were reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/9/2026.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.H6 component code: g07002 no device problem found.H6 component code: c22 - photo analysis.Additional information: d9, h3, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to eth for evaluation.Visual inspection revealed that one winding former and one needle suture in two sections outside the foil packet were received for analysis.The product code pdp148 is double armed.During visual inspection of the returned sample, the swage and attachment area were noted to be as expected.The suture pieces were examined, and the ends were found to be cut and crushed caused by an unidentified object.A photo was provided showing one dispensed suture piece and one winding former with a needle suture outside the foil packet associated with product code pdp148.As the suture is absorbable and the duration and conditions of environmental exposure could not be determined, functional testing was not performed.To prevent this kind of damage: care should be taken to avoid damage to the strand when handling, including avoiding the crushing or crimping action of surgical instruments such as needle holders and forceps.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Given the current condition of the returned sample, no conclusion could be reached as to what caused the reported complaint.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: PDS PLUS SUTURE 30"(75CM) 5-0 VIO
• 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: 24551402
• Report Number: 2210968-2026-02409
• Device Sequence Number: 15799306
• Product Code: NEW
• UDI-Device Identifier: 10705031047921
• UDI-Public: (01)10705031047921(17)300228(10)106TH4(21)
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K061037
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PDP148H
• Device Lot Number: 106TH4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2025
• 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