MAUDE Adverse Event Report: ETHICON INC. GUT PL FAG UD 18IN 5-0 S/A PC-1 PRM MP; SUTURE, ABSORBABLE, NATURAL

Catalog Number	1915G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
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.H6 component code: g07002 device not returned a review of the batch manufacturing records was conducted, and no related non-conformances were identified.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.It was reported that "while attempting to suture patient's forehead, suture material repeatedly broke apart" * please confirm the number of sutures that broke during this procedure.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.Related events captured via: 2210968-2024-04359 2210968-2024-04360.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2024; and a suture was used.During the procedure, the suture broke apart while attempting to suture patient's forehead.Changed to another one but the same thing happened again.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint: (b)(4).Date sent to the fda: 5/22/2024.Additional information was requested, the following was obtained: it was reported that "while attempting to suture patient's forehead, suture material repeatedly broke apart" please confirm the number of sutures that broke during this procedure.Unknown; sutures were placed but as the next one was being placed, the last suture would split apart.Is this device or samples available for analysis? if yes, to whom should the shipper kit be sent? (please provide contact name, department, street address including zip, no po box please, email address, and phone number) yes and no.I do not have the actual sutures, but i do have the remaining box of sutures.Please send shipper kit to: (b)(6).Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) (b)(6) , risk & claims analyst.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: GUT PL FAG UD 18IN 5-0 S/A PC-1 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• 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: 19116411
• Report Number: 2210968-2024-04359
• Device Sequence Number: 18036312
• Product Code: GAL
• UDI-Device Identifier: 10705031002913
• UDI-Public: 10705031002913
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2024

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: 1915G
• Device Lot Number: TKMACZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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