MAUDE Adverse Event Report: ETHICON INC. SILK BLK 18IN 2-0 S/A FS; SUTURE, NONABSORBABLE, SILK

Catalog Number	685G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a breast reduction procedure in 2025 and suture was used.During the procedure, it was reported by the sales rep, that during breast reduction the needle broke in half.Device is available return.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.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.Mismatch information: expected one 685g; lot#: 106bmb but instead we received (1) 685; lot#: unk; (3 pkg only) 685; lot#: 106bmb and (2 pkg only) 685; lot#: 10583d.Product received under awb#: (b)(4).From: (b)(6).As the analysis site is hsa the samples will remain on hold at cg labs until the mismatch is resolved.Please confirm if the additional lot#: 10583d belongs to this complaint.1.Could you please clarify if the returned device belongs to this complaint? 1a.If yes, did a device malfunction occur during the same procedure? 2.If not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction.4.If the product doesn't belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to ethwcqcom@its.Jnj.Com with the ups, dhl or fedex.A device has been received; however, clarification is requested whether the product belongs to this complaint.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 10/28/2025.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.Corrected information: d4 udi.The following information was requested: none of the wrong products received for analysis had the faulty lot number.Could you please let us know so we can discard them or advise if the products are required to be returned? please provide the source or name of person providing answers to follow-up questions: expected: (1)685g; lot #: 106bmb.Received: (1) 685; lot #: unk; (3 pkg only) 685; lot# 106bmb and (2 pkg only) 685; lot#10583d.The following information was received: i apologize for the delay.They gave me all of the suture they had as a precaution just incase it was the lot(s) that were faulty.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/4/2025.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.H6 component code: g07002 pending evaluation of returned device.Additional information: d9, h3, h6.A device has been received, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
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, d9, h3 h3 investigation summary: the product was returned to ethicon for evaluation.Three empty labeled winding formers were received for analysis.Product code 685g.The visual assessment of the returned winding former.No suture and needle were returned for analysis.As per this condition, the event described could not be confirmed.If additional information is made available, the investigation will be updated as applicable.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d h 3.Device evaluated by manufacturer?, d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer?, h 3.Device evaluated by manufacturer?, h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions additional h3 investigation summary: the product received for analysis was 685g visual inspection and metallurgical analysis were performed on the returned product.A failed suture needle, labeled as (b)(4), was submitted to herrera, stafford and associates, llc (hsa) for fractographic evaluation on november 19, 2025.The component was identified as product code 685g.It was requested that hsa assess the fracture mode of the failure.A fracture was observed at the suture attachment of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation of (b)(4) revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.This was a ductile fracture.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, 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.

• Brand Name: SILK BLK 18IN 2-0 S/A FS
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22748712
• Report Number: 2210968-2025-09197
• Device Sequence Number: 18305566
• Product Code: GAP
• UDI-Device Identifier: 10705031008229
• UDI-Public: (01)10705031008229(17)300131(10)106BMB
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/03/2026

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: 685G
• Device Lot Number: 106BMB
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 10/07/2025; 11/10/2025; 12/07/2025; 01/26/2026
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 10/29/2025; 12/04/2025; 12/09/2025; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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