MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 8X18IN 0 S/A CTXB CR; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDPB776D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device evaluation pending.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.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested, and the following was obtained via: when did the suture detached from the needle (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? unk.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections; the device has been received at (b)(6) and will be shipped.Please check rmao.Tracking number: (b)(4).Provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq): (b)(6).
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.During the procedure, it was reported by a sales rep that the suture was detached from the needle easily.It was a control release needle.Another product was used to complete the case.Further details are not provided from the hp.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.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: h6, d9, h3 h3 investigation summary: the product was returned to ethicon for evaluation.One empty foil and one winding former with seven used needles and one needle-suture piece were returned for evaluation.Product code pdpb776d which is a control release and requires eight strands per packet.Upon visual inspection of the detached needles, the swage and attachment area were noted to be as expected.The barrel hole of the needles was examined with magnification, and no suture remnant was observed.The five sutures were not returned for evaluation to determine the assignable cause.In addition, the needle-suture piece was visually inspected, and no anomalies or issues related to pull-off was observed during the evaluation.As the product code contains an absorbable suture.Since the sample was received open, the functional test could not be performed due to undetermined exposure time to the environment.No conclusion could be reached as to what caused the reported complaint.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: PDS+ VIO 8X18IN 0 S/A CTXB CR
• 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: 22020205
• Report Number: 2210968-2025-05353
• Device Sequence Number: 8815365
• Product Code: NEW
• UDI-Device Identifier: 10705031218857
• UDI-Public: (01)10705031218857(17)260930(10)104CUC
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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 Expiration Date: 09/30/2026
• Device Catalogue Number: PDPB776D
• Device Lot Number: 104CUC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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