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

Catalog Number	K833H
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 an unknown procedure in 2025 and suture was used.During the procedure, it was reported by the sales rep that during an unknown procedure, the needled broke while suturing.The needle was found.Device is available for 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, part 4 subpart b.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances 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.- was the needle piece(s) retrieved during the same procedure? - were x-rays taken to locate the needle piece(s)? - what measures were implemented to retrieve the broken piece? - was there any additional tissue damage resulting from the search for the needle piece? - could you kindly perform the follow-up attempt for the product return? please ensure that the shipment tracking number is provided.- please provide the source or name of person providing answers to follow-up questions.
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: a failed suture needle, labeled as (b)(4), was submitted to herrera, stafford and associates, llc (hsa) for fractographic evaluation on september 11, 2025.The component was identified as product code k833h.It was requested that hsa assess the fracture mode of the failure.According to the information, it was reported breakage needle.The product received for analysis was k833h.Visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed at the tip of the needle.One side of the needle was received; the mating fracture surface was not provided 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.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/16/2025.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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 information: d9, h3, h6.H3 investigational summary: the product was returned to ethicon for evaluation.One empty overwrap packet and one needle -suture piece were received for analysis.Product code k833h.Upon visual inspection of the sample, it was observed that the needle was observed to be broken at the tip area.The sample will be shipped to hsa for further analysis due to the needle breakage.Also, marks that appear to be by use of the surgical instrument were observed near the damage.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.No conclusion could be reached due to the sample needs additional evaluation by hsa.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.

• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22810037
• Report Number: 2210968-2025-09365
• Device Sequence Number: 18102066
• Product Code: GAP
• UDI-Device Identifier: 10705031044388
• UDI-Public: (01)10705031044388(17)47391(10)104CL5
• 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
• Report Date (Section B): 11/05/2025

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: 104CL5
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 08/19/2025; 11/04/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/16/2025; 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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