MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 12IN 10-0 D/A CS160-6; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	9000G
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2024 and suture was used.During the procedure, it was reported by the customer, that one of their surgeons stated the suture he has been using for years seems to have something wrong.The surgeon stated that the tip of the suture goes in smooth, but the end seems to be wider.He stated that the suture part is wider or larger than the tip of the needle, so that it causes him to tug on it.Three of the six sutures he used were bad.There was no patient consequences reported.Sterile sutures left over from same lot to be returned.There were no adverse consequences 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-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.1st additional information request message sent via email on october 28, 2024: for this single event ((b)(4)): please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.It was reported that multiple events have presented the same reported evented.Please confirm the number of patients affected by these issue? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).Please provide information requested below for each patient/event.What are the procedure name(s) and date(s)? can you identify the lot numbers and product code of the product that was used? what is the quantity involved per procedure? were there patient consequences? if yes, please specify.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).Please confirm if the device(s) are available for product return.If yes, provide the quantity of devices available to be returned and the status of the device(s) as it/they has/have not been received for analysis.If the device(s) has/have been shipped, provide the shipment tracking details.
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.H6 component code: g07002 no device problem additional h3 investigation summary the product was returned to ethicon for evaluation.One open box with four unopened samples was received for analysis.Product code 9000g.Upon visual inspection of the returned samples, the needle sutures were dispensed without problems.The sutures were examined, and no anomalies or defects were observed.In addition, the sutures were measured, and the results met the requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.No anomalies were noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional information was requested, and the following was obtained: it was reported that in multiple procedures has occurred the same reported event.- please confirm the number of patients affected by these issue? 2 - have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).Yes, but no follow up from ethicon (b)(4).Please provide information requested below for each patient/event.- what are the procedure name(s) and date(s)? dsaek and keratoplasty ¿ date (b)(6) 2024 - can you identify the lot numbers and product code of the product that was used? lot number 10193u ¿ product code 9000g - what is the quantity involved per procedure? 3 - were there patient consequences? if yes, please specify.No, the surgeon had to tug to get suture in.Surgeon works with human cornea and its not recommended to put multiple holes in tissue.- please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).Leslie tindall - materials manager - please confirm if the device(s) are available for product return.If yes, provide the quantity of devices available to be returned and the status of the device(s) as it/they has/have not been received for analysis.If the device(s) has/have been shipped, provide the shipment tracking details.3 unopened sutures sent back.Used sutures are directly put in sharps container.

• Brand Name: ETHLN BLK 12IN 10-0 D/A CS160-6
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20563200
• Report Number: 2210968-2024-11230
• Device Sequence Number: 7988822
• Product Code: GAR
• UDI-Device Identifier: 10705031022300
• UDI-Public: (01)10705031022300(17)290430(10)10193U
• 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
• Report Date (Section B): 11/22/2024

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: 9000G
• Device Lot Number: 10193U
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2024
• 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