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

Catalog Number	J442H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2025 and suture was used.During the procedure, surgeon was attempting to reload needle after throwing a stitch with needle driver when the tip of needle broke off.Surgeon was 100% certain needle remnant was not in the patient.The needle tip was not recovered.Surgeon offered x-ray by staff in attempt to locate but declined.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.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.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.Additional information was requested, and the following was obtained via: just heard back with answers to the below questions: were there any unexpected outcomes or complications resulting from the prolonged surgery time? no.Which tissue was being sutured when the event occurred? skin.Was additional dissection required in other organs/tissues other than the target tissue? no.Was there any change in the patient¿s post operative care due to the prolonged procedure? no.Can you identify the lot number of the product involved? 106hu7.Additional h11.Was surgery delayed due to the reported event? yes, if yes, number of minutes: 10 minutes, action taken when event occurred? attempted to locate needle tip, unsuccessful but surgeon confident it was not in patient, was procedure successfully completed? yes, were fragments generated? yes, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no, is the patient part of a clinical study unknown, (b)(6), device property of none, device in possession of none, d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
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.Additional information: h6, h4, d4 a manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.

• Brand Name: VCL CT BRD UD 27IN 3-0 S/A FS-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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: 23268159
• Report Number: 2210968-2025-11666
• Device Sequence Number: 18667559
• Product Code: GAM
• UDI-Device Identifier: 10705031039933
• UDI-Public: (01)10705031039933(17)300131(10)106HU7
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022269
• 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): 12/05/2025

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 Catalogue Number: J442H
• Device Lot Number: 106HU7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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