MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 4-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J441H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: (b)(4) device not returned.Attempts have been made to retrieve the device.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.What is the initial procedure? could you please clarify when did the issue occurred? pre-op or intra-op? what is the procedure date? what was used to complete the procedure? a manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The suture detached.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 09/23/2021.H6 component code: g07002 - device not returned.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.The following information was requested, but unavailable: 1.What is the initial procedure? lar.2.Could you please clarify when did the issue occurred? pre-op or intra-op? intra op.3.What is the procedure date? (b)(6) 2021.4.What was used to complete the procedure? change a new one.5.Could you please confirm device's status, (it indicates not available - discarded)? or discarded.

• Brand Name: VCL CT BRD UD 27IN 4-0 S/A FS-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12357222
• Report Number: 2210968-2021-07615
• Device Sequence Number: 17092478
• Product Code: GAM
• UDI-Device Identifier: 10705031039919
• UDI-Public: 10705031039919
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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 Expiration Date: 02/29/2024
• Device Model Number: J441H
• Device Catalogue Number: J441H
• Device Lot Number: PC2331
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/23/2021
• Patient Sequence Number: 1