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

Catalog Number	PDP334H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep that during the hernia procedure, three different sutures on the same lot was used.The first one the needle got broken off.They used two more sutures and both needles got bent.The needles were successfully retrieved from patient's body.Devices are returning.
Additional Manufacturer Narrative
Product complaint(b)(4).Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.-did the reported issue contribute to any patient adverse consequences? how many needles fell on the patient or remained embedded in the tissue.-was the needle(s) retrieved during the same procedure? -were x-rays taken to locate the needle (s) piece(s)? -what measures were implemented to retrieve the needle (s)? -was there any additional tissue damage resulting from the search for the needle piece? - is there any plan in place to remove the needle piece in the future? - if so, could you please provide the scheduled date for the removal? - in which tissue structure was the broken needle located? - what is the surgeon¿s opinion of the potential consequences for the patient? - could you kindly perform and document the follow-up attempt for the product return? furthermore, please ensure that the shipment tracking number is recorded in the notes or rmao sections.- please provide the source or name of person providing answers to follow-up questions: the device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: h 3.Device evaluated by manufacturer? additional information: h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions.H6 component code: g07002 - no device problem found.H3 investigation summary: the product was returned to ethicon for evaluation.Twenty (20) representative unopened samples were received for analysis.Product code pdp334h.Upon initial inspection of the samples, no external damages were observed on the external packets.As per the sampling plan, a visual inspection was performed on thirteen (13) samples, the packets were opened, and the swage and attachment area were noted to be as expected.The tip and body of the needles were examined under magnification, and no defects or needle breakage were found.In addition, the samples were tested by resistance test to needle and met the requirements.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device 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.

• 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: 24597051
• Report Number: 2210968-2026-02568
• Device Sequence Number: 18532014
• Product Code: NEW
• UDI-Device Identifier: 10705031048072
• UDI-Public: (01)10705031048072(17)291231(10)105S27
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: PDP334H
• Device Lot Number: 105S27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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