MAUDE Adverse Event Report: ETHICON INC. SILK BLK 18IN 6-0 D/A G-6 PRM; SUTURE, NONABSORBABLE, SILK

Model Number	769G
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an eye surgery on (b)(6) 2023 and suture was used to do corneal traction.During the ablation of the traction, persistence of thread's fibers in corneal thickness.Multiple ablation attempts but failed.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).His 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 device not returned.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.Name of surgical procedure? what was the indication of the procedure? did the silk suture fray intra-op? if no, please explain the issue with the suture.Were the multiple ablation attempts made during the initial procedure? was the procedure completed successfully? did the patient experience any adverse consequences? if yes, please explain and describe.Did the multiple ablation attempts during the procedure cause any adverse patient consequences? if yes, please explain.Was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time, as it stated multiple ablation were attempted? was a re-operation planned or performed due to the failed ablation attempts? if yes, please explain.What is the patient¿s current status? if applicable, will product be returned? if so, please provide the return date and tracking information.
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.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Additional information was requested and the following was obtained: date and name of surgical procedure? (b)(6) 2023.Trabeculectomy surgery.What was the indication of the procedure? the silk was used as a corneal traction thread in order to decline the eyeball downwards.Did the silk suture fray intra-op? if no, please explain the issue with the suture.I don't know i noticed the persistence of fibers after the removal of the thread at the end of the procedure.Were the multiple ablation attempts made during the initial procedure? one-time ablation.Was the procedure completed successfully? persistence of fiber in the thickness of the cornea impossible to remove.Did the patient experience any adverse consequences? if yes, please explain and describe.No, good tolerance of the presence of fibers.Did the multiple ablation attempts during the procedure cause any adverse patient consequences? if yes, please explain.No.Was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time, as it stated multiple ablation were attempted? not yet, 1 month and a half back.Was a re-operation planned or performed due to the failed ablation attempts? if yes, please explain.No.What is the patient¿s current status? good tolerance.Note that i regularly use this suture for the same indications and this is the only time this incident has occurred.

• Brand Name: SILK BLK 18IN 6-0 D/A G-6 PRM
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; col salvacar 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17137836
• Report Number: 2210968-2023-04340
• Device Sequence Number: 17585796
• Product Code: GAP
• UDI-Device Identifier: 10705031010451
• UDI-Public: 10705031010451
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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 Model Number: 769G
• Device Catalogue Number: 769G
• Device Lot Number: SLMLDC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2018
• 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