MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 5-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	A182H
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported by a sales rep that the product could not be passed the acceptance inspection because of contamination with metal pieces.It could be considered that this product is not a special inspection product.It was not a control release needle.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/12/2025.H6 component code: g07002 - pending evaluation of returned device.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.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: please confirm, how many devices demonstrated the alleged deficiency? provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).Additional information was requested; the following was obtained: could you please elaborate further on the issue reported with the product? unk.Where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?) unk.Please describe the type of foreign matter that was observed.What was the foreign matter¿s appearance? what was the texture? unk.Are there any photos of the foreign matter available? yes.Is it possible that the foreign material fell into packaging upon opening of device? unk.Was the product seal on the foil still intact when the package was opened? unk.Could you kindly perform and document the follow-up attempt for the product return? furthermore, please ensure that the shipment tracking number is recorded in the notes or rmao sections and return all relevant packaging material? the device has been received at sukagawa and will be shipped.Please check rmao.Tracking number: (b)(4).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, h4.H3 investigation summary: the product was returned to ethicon for evaluation.One sealed box with thirty-six (36) representative unopened samples and one open box with thirty-four (34) representative unopened samples with a total of seventy (70) representative unopened samples were received for analysis.Product code a182h.According to the sampling plan, a visual inspection was conducted on thirteen (13) samples.Debris from the aluminum foil packages were observed inside the overwrap packets.Based on these observations, the remaining fifty-seven (57) samples were subsequently examined; in total, debris from the aluminum-foil packages were detected in fifty-one 51 packets (51 of 70 samples).To complement this analysis, two photos were included, and showing two boxes and some packets that pertain to product cod a182 based on the information currently available, the foreign matter was identified during the investigation of the sample received.This product issue will be addressed through ethicon quality system.A manufacturing record evaluation was performed for the finished device shmmdl / a182h batch number, and no non-conformances were identified.Additional information was requested, and the following was obtained via: how many primary packages in each box are contaminated with metal pieces? unk, maybe 2 please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq),(b)(6).Please confirm, how many devices demonstrated the alleged deficiency? 2box provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).(b)(6).

• Brand Name: SILK SUTURE 18"(45CM) 5-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23790354
• Report Number: 2210968-2025-13960
• Device Sequence Number: 21450339
• Product Code: GAP
• UDI-Device Identifier: 10705031022966
• UDI-Public: (01)10705031022966(17)270630(10)SHMMDL
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: A182H
• Device Lot Number: SHMMDL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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