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 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).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 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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During suturing, when pulling the suture, it broke from the root part of the needle and detached.All products were opened.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).Date sent to the fda: 12/19/2025.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.H6 component code: g07002 no device problem found.Additional information: h3, h6.H3 investigational summary: the product was returned to eth for evaluation.Two empty foils, four empty labeled winding formers, four used needles and five suture pieces that pertains to product code vr935 were received for analysis.The swage and attachment area appeared as expected in all needles, with remnant suture observed in the barrel hole of one needle.The remaining three needles, were observed without remnant suture.Given the current condition of the returned sample, it is not possible to determine what caused the pull off - suture needle.The suture pieces showed signs of degradation, and the foil packaging exhibited no visual anomalies.Functional testing could not be performed due to the degraded condition of the suture, which may have contributed to the detached needle or broken suture.The time of environmental exposure for the suture could not be determined, and no conclusion could be reached regarding the cause of the reported incident.All devices are manufactured, inspected, and released to approved specifications.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device vr935; ueccgke0 number, and no non-conformances were identified.Vr935 manufacturing date: 05.14.2024 expiration date: 10.31.2029 additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• 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: 23646173
• Report Number: 2210968-2025-13189
• Device Sequence Number: 4903876
• 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,Followup

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: 11/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/19/2025
• 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