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

Model Number	J417H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (b)(4).Date sent to the fda: 3/28/2022.(b)(4).The following information was requested, but was unavailable: was the needle it retrieved during the same surgical procedure? was there any additional tissue damage as a result of searching for the needle piece? was additional dissection required in other organs/tissues other than the target tissue? what is the most current patient health status and condition? lot number? device return status/follow up? 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.Related to: 2210968-2022-02219, 2210968-2022-02220, 2210968-2022-02221.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.During the procedure, the suture pops off when it shouldn't.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 05/18/2022.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.H3 analysis summary: one sealed box, twelve packets, two paper lids, and two empty winding formers of product code j417h were returned to ethicon inc for analysis with the packaging closed.Upon initial inspection to the samples no external damages were observed on the packets.In order to evaluate the conditions of the returned samples, thirteen packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issues on the suture and no defects were observed during the evaluation.A functional test was performed using an instron and the pull force was above the minimum requirement.The devices performed without any defect noted.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.H6 component code: g07002 ¿ device from same lot.Related events captured via: 2210968-2022-02219, 2210968-2022-02220, 2210968-2022-02221, 2210968-2022-02222.

• Brand Name: VCL CT BRD UD 27IN 2-0 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.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13935247
• Report Number: 2210968-2022-02222
• Device Sequence Number: 4012747
• Product Code: GAM
• UDI-Device Identifier: 10705031039681
• UDI-Public: 10705031039681
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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: 09/30/2026
• Device Model Number: J417H
• Device Catalogue Number: J417H
• Device Lot Number: RLMMCK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2021
• 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