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

Catalog Number	J416H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6 component code: g07002 device not returned.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide the patient's demographic information including age, weight, bmi at the time of index procedure date of the index surgical procedure? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? what instruments were used to grasp the needle? where was the needle grasped during use? date the needle tip was removed from the patient? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? lot number?.
Event or Problem Description
It was reported that a patient underwent a dual chamber pacemaker procedure on an unknown date and suture was used.During the end of the procedure, the physician recognized that the suture needle had broken during the process of suturing the pacemaker pocket.A thorough examination was performed to locate the broken needle including an intra-operative chest x-ray.The physician determined that the x-ray did not reveal that the broken suture was retained in the body despite not being able to locate it on the field or in the general surgical area and made a decision to transfer the patient to the cath lab holding recovery area where a higher resolution image could be obtained.The image revealed that the suture tip was retained in the superficial skin layer.The physician brought the patient back to the ep (electrophysiology) lab suite, opened the pocket, located the suture needle tip and removed it.The pacemaker pocket was closed with a new suture, steri-strips, a topical skin adhesive, and a band-aid without incident.Additional information was requested.
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: a4, b3, b7.Additional information was requested, and the following was obtained: 1.Patient's demographic information including age, weight, bmi at the time of index procedure: age: 54, wt: 106.82kg, 2.Date of the index surgical procedure: on (b)(6)2024, 3.Date the needle tip was removed from the patient? the needle was retained, 4.What was the tissue condition (normal, thin, calcified, fragile, diseased)? normal, 5.What instruments were used to grasp the needle, debakey forceps, 8" needle driver.6.Date the needle tip was removed from the patient? the needle was retained needle tip was removed on the same day (b)(6) 2024 7.Did the operating surgeon observe any suture deficiency or anomaly before during, after the suture placement or during any re-operation? no 8.Other relevant patient history/concomitant medications? atrial fibrillation, dyspnea, gerd, pre-diabetic, sick sinus 9.What is the physician¿s opinion as to the etiology of or contributing factors to this event? unknown.Stated it may have broken when he grasped the suture with the needle driver 10.What is the patient's current status? discharged.11.Lot number? unknown.

• Brand Name: VCL CT BRD UD 27IN 3-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21157869
• Report Number: 2210968-2025-00523
• Device Sequence Number: 8594504
• Product Code: GAM
• UDI-Device Identifier: 10705031039667
• UDI-Public: 10705031039667
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: J416H
• 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: 01/03/2025
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 01/23/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American