MAUDE Adverse Event Report: ETHICON INC. COATED VICRYL; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP958H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent to the fda: 5/6/2026.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 information was requested, the following was obtained: it was reported that "two sutures (same product code-vcp958) used that both snapped" and "the needle was broken during a routine suturing of a patient with a higher".Please confirm whether these two issues ¿ suture snapping and needle breakage ¿ occurred in two separate events, procedures, or patients.These were 2 separate events- apologies for the inclusion of additional data on separate event.(b)(4) should be for 2 instances where suture vcp958 snapped while in use.Events where needles broke were reported under different pcs 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.Unknown were there any patient consequences? unknown were there any unexpected outcomes or complications as a result of the prolonged surgery time? unknown please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).(b)(6) - surgical tech no additional information will be made available on this incident of suture snapping.Have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? (b)(4).If this event occurred during multiple procedures, would you kindly create a product complaint for each event and provide the corresponding reference number(s)? happened during 1 procedure.Please provide the lot numbers for the two vcp958h products associated with (b)(4).Unknown and not going to be available from account provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).(b)(6).Surgical tech.No additional information will be made available on this incident of suture snapping.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used.It was reported to the sales rep by the surgical tech in the room, that there were two sutures used that both snapped.Not the needle, but the actual suture.The needle was broken during a routine suturing of a patient with a higher bmi.She noted that their needle graspers are functioning correctly and is unsure of the cause of the breakage.Previously reported a separate pi for the product code at same facility where needle broke.This report should be linked to (b)(4).The device was not returning.There were no patient consequences reported.Additional information was requested.

• Brand Name: COATED VICRYL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.; 1000 route 202; raritan 08869 0151
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25095303
• Report Number: 2210968-2026-04965
• Device Sequence Number: 15894456
• Product Code: GAM
• UDI-Device Identifier: 10705031056213
• UDI-Public: 10705031056213
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• 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

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: VCP958H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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