MAUDE Adverse Event Report: ETHICON INC. SILK BLK 30IN 2-0 S/A SH; SUTURE, NONABSORBABLE, SILK

Catalog Number	K833H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H6 component code: g07002 pending device evaluation the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Note: related events reported via 2210968-2024-00679, 2210968-2024-00680, and 2210968-2024-00681.
Event or Problem Description
It was reported that a patient underwent an abdominal closure on an unknown date and suture was used.During the procedure, the surgeon was suturing intra abdominally, and the needle fell off of the suture when the surgeon was pulling the suture strand through the tissue.There were no adverse patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/30/2024.H6 component code: g07002 no device problem found.Additional information was requested, the following was obtained: device return status.Please document the shipment tracking number: fedex tracking # (b)(4) (sent in two packages and did not think to record item on scanned ticket) please provide the source or name of person providing answers to follow-up questions: (b)(6).H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned product determined that it received a needle that pertained to the product code k833h.During the analysis of the returned sample, the swage and attachment area were noted to be as expected and the needle was still attached to the suture piece.The suture piece was examined and the end was noted to be cut probably caused by a surgical instrument.This cause the event reported.As per the condition of the returned sample, the functional test could not be confirmed.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned product determined that it received two open samples that pertained to the product code k833h.In order to evaluate the condition of the returned samples, the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during the evaluation.A functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.

• Brand Name: SILK BLK 30IN 2-0 S/A SH
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18586873
• Report Number: 2210968-2024-00681
• Device Sequence Number: 15223015
• Product Code: GAP
• UDI-Device Identifier: 10705031044388
• UDI-Public: 10705031044388
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2024

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: K833H
• Device Lot Number: TJBJLJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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