MAUDE Adverse Event Report: ETHICON INC. VCL RAP UD 27IN 3-0 S/A PS-1 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VR935
Medical Device Problem Codes	Break (1069); 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).The following information was requested, but unavailable: how many sutures broke? please specify below by product code and lot number: product code vr935 - lot uacdzce0: product code vr935 - lot ueccgke0: how many needles detached? please specify below by product code and lot number: product code vr935 - lot uacdzce0: product code vr935 - lot ueccgke0.Investigation summary = > the product was returned to ethicon for evaluation.Two paper lids, two empty winding formers and one needle were received for analysis.Product code vr935.Upon visual inspection of the product, it was observed that the suture was not returned for evaluation.The needle was visually inspected, the swage and attachment area were noted to be as expected; however, marks that appear to be caused by a surgical instrument were observed on the body needle.The barrel hole of the needle was examined, and some sutures fragments were noted to be still attached to the barrel hole.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Given the current condition of the returned sample, no conclusion could be reached as to what caused the reported complaint.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.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 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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During an unknown procedure at the wards/icu, when the needle was pulled, the sutures were broken or detached from the needle swage.It was not a control release needle.Another product was used to complete the case.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL RAP UD 27IN 3-0 S/A PS-1 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24459382
• Report Number: 2210968-2026-02051
• Device Sequence Number: 9304367
• Product Code: GAM
• UDI-Device Identifier: 10705031134799
• UDI-Public: (01)10705031134799(17)291031(10)UECCGKE0
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033746
• 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
• Report Date (Section B): 02/26/2026

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: VR935
• Device Lot Number: UECCGKE0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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