MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 18IN 4-0 S/A P-3 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z464H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.The following information was requested, but unavailable: when did the alleged deficiency occur (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? if different, please explain.Unk.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Attempts are being 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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The swage part of two needles were broken.No needle pieces fell into the surgical field.It was not a control release needle.Another product was used to complete the case.There were no adverse consequences to the patient.Further details are not provided from the hp.
Additional Manufacturer Narrative
Product complaint # (b)(4) corrected information: d 4.Primary udi number, d 9.Device available for evaluation? h 3.Device evaluated by manufacturer? additional information: d 4.Lot, d 4.Expiration date, d 9.Device available for evaluation? d 9.Is device returned to manufacturer? h 4.Device manufacture date, h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions h3 investigation summary the product received for analysis was z464h.Visual inspection and metallurgical analysis were performed on the returned product.Two failed suture needles, labeled as (b)(4), were submitted to herrera, stafford and associates, llc (hsa) for fractographic evaluation on january 5, 2026.The components were identified as product code z464h.It was requested that hsa assess the fracture mode of the failures.A fracture was observed at the suture attachment of sample a and at the suture attachment of sample b.The needles were received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needles.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation of (b)(4) revealed the fractures were composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage observed coincidental to the fractures provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.These were ductile fractures.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.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: PDSII VIO 18IN 4-0 S/A P-3 PRM MP
• 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: 24080244
• Report Number: 2210968-2026-00546
• Device Sequence Number: 21331428
• Product Code: NEW
• UDI-Device Identifier: 10705031462519
• UDI-Public: (01)10705031462519(17)291231(10)10614S
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183183
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: Z464H
• Device Lot Number: 10614S
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2025
• 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