MAUDE Adverse Event Report: ETHICON INC. SILK BLK 30IN 3-0 S/A SH; SUTURE, NONABSORBABLE, SILK

Catalog Number	K832H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent an unknown procedure on an unknown date and suture was used.The needle falls into patient.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint (b)(4) additional information: h6 component code: g07002 - device not returned additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Was there any adverse consequence associated with the patient? if yes, please provide more details it was reported that the needle falls into the patient, could you please clarify if the needle pulled-off from the suture or if the needle broke? was the needle retrieved during the same procedure? were x-rays taken to locate the needle? what measures were taken to retrieve the needle? was there any additional tissue damage as a result of searching for the needle? does the needle remain in the patient¿s tissue? if yes, is there any plan in place to remove the needle in the future? if yes, please provide the scheduled date.What tissue structure the needle was located? what is the surgeon's opinion of consequences to the patient? device return status.Please document the shipment tracking number: however we also received additional product that we do not have complaints for: product code: k832- silk suture, lot#scbeda quantity received 1 product code: silk suture - k832, lot#spbdma quantity received 3 please advise of the complaint reference, event and details, procedure name, date, etc.For these additional products returned.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.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, 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.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 3/19/2024.H6 component code: g07002 no device problem found.Additional information: d9, h3, h6.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional test evaluation were conducted on the returned devices.Visual analysis of the returned sample determined that nineteen packets of product code k832h were received for evaluation.Upon initial inspection, of the samples, no external damages were observed on the packets.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.A functional test was performed using instron equipment and the pull force result was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.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 3-0 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 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18841383
• Report Number: 2210968-2024-02458
• Device Sequence Number: 20704312
• Product Code: GAP
• UDI-Device Identifier: 10705031044364
• UDI-Public: 10705031044364
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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: K832H
• Device Lot Number: TEBBQK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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