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

Catalog Number	680H
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
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.Photo analysis summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: as per photos provided for analysis, one opened box was observed with an individual packet outside that pertains to product code 680h56.During the visual assessment in the picture provided a red line was to be noted in the overwrap packet at the seal area.As per internal specification, this is considered as foreign matter.The foreign matter during the visual assessment has been correlated to the manufacturing process as a class 3 defect as per process specification.The following event will be managed as a nonconformance record.Based on the information currently available, a foreign matter issue was identified during the investigation of the sample received.This product issue will be addressed through the quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Attempts are being 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.H6 component code: g07002 ¿ device not returned.A review of the batch manufacturing records was conducted, and no related non-conformances were identified, however, the event will now be managed as a new nonconformance record.Related events captured via 2210968-2023-07729, 2210968-2023-07731, 2210968-2023-07732, 2210968-2023-07733, 2210968-2023-07734.
Event or Problem Description
It was reported that the customer received a thread pack with red marked and opened threads.The packaging blister has the red marking and these blisters are also open.There was no patient involvement.No further information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/22/2023.H6 component code: g07002 pending evaluation of returned device additional information: 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.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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/18/2024.H6 component code: g07002 no device problem found.H3 investigational summary: visual inspection was conducted on one unopened sample that pertain to product code 680h, lot tabbru.The ethicon san lorenzo team performed a further analysis to determine if the complaint represent a defect/or a process deviation.According to the results: the splice (red tape) can be seen between the copolymer material and the tyvek material by the packaging process at san lorenzo.Based on the information currently available, it was confirmed an open seal defect on the portion where the splice material is present.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.H3 investigational summary: visual inspection was conducted on thirty samples that pertain to product code 680h, lot tabbru to evaluate the condition of the returned sample, the packets were examined for visual defects: appearance, color package, wrinkles in the seal area, continuous seals, seal margins, over-sealing, and damage (torn, punctured) and none was observed.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 0 S/A FSL
• 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: 17931268
• Report Number: 2210968-2023-07730
• Device Sequence Number: 6416198
• Product Code: GAP
• UDI-Device Identifier: 10705031008106
• UDI-Public: 10705031008106
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2024

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: 680H
• Device Lot Number: TABBRU
• 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: 09/15/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 01/04/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 12/22/2023; 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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