MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 2-0 S/A UR-6; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J602H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 surgery, it was not a control release needle.The needle tip was broken.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/20/2024.H6 component code: g07002 - device not returned this report is being submitted pursuant to the provisions of 21 cfr.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.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: - did any needle piece(s) fall into the patient? *if yes, o was the needle piece(s) retrieved during the same procedure? o were x-rays taken to locate the needle piece(s)? o what measures were taken to retrieve the broken piece(s)? o was there any additional tissue damage as a result of searching for the needle piece(s)? *if not retrieved, in what tissue structure the needle piece(s) were retained? is there is any plan in place to remove the needle piece(s) in the future? please provide details.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).- please provide lot number.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.
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.Additional information was requested and the following was obtained: did any needle piece(s) fall into the patient? we have been not reported that the needle piece fell into the patient.We could not get further inormation.? ?*if yes, ?o was the needle piece(s) retrieved during the same procedure? ?o were x-rays taken to locate the needle piece(s)? ?o what measures were taken to retrieve the broken piece(s)? ?o was there any additional tissue damage as a result of searching for the? ? ? ? ? ? ?needle piece(s)? ? ? *if not retrieved, in what tissue structure the needle piece(s) were retained? is? ? ? ? there any plan in place to remove the needle piece(s) in the future? please provide details.? please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).(b)(6).Please provide lot number.Unk.
Additional Manufacturer Narrative
(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.Corrected: h6 type of investigation (b18 - device discarded).

• Brand Name: VCL CT BRD VIO 27IN 2-0 S/A UR-6
• 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: 20268482
• Report Number: 2210968-2024-10112
• Device Sequence Number: 7419394
• Product Code: GAM
• UDI-Device Identifier: 10705031041615
• UDI-Public: 10705031041615
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 11/18/2024

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: J602H
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 10/02/2024; 11/01/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/28/2024; 11/18/2024
• 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