MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, NATURAL

Catalog Number	811H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent a total hysterectomy on (b)(6) 2924, and suture was used.The chromic gut suture kept breaking when closing the deep tissue layer.After a 5 minute delay the case was completed with a new suture without patient harm.Additional information was requested.
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.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.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? what tissue was being sutured when the event occurred? was additional dissection required in other organs/tissues other than the target tissue? was there any change in the patient¿s post operative care due to the prolonged procedure? please provide the lot number for all 811h reported.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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.H6 component code: g07002 ¿ device not returned.Related events captured via: 2210968-2024-03444.
Event or Problem Description
It was reported that the patient underwent a total hysterectomy on (b)(6) 2024, and suture was used.The chromic gut suture kept breaking when closing the deep tissue layer.After a 5 minute delay the case was completed with a new suture without patient harm.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/12/2024 additional information was requested, the following was obtained: - were there any unexpected outcomes or complications as a result of the prolonged surgery time? no - what tissue was being sutured when the event occurred? deep tissue - was additional dissection required in other organs/tissues other than the target tissue? no - was there any change in the patient¿s post operative care due to the prolonged procedure? no - please provide the lot number for all 811h reported: rkmdap and rlmjmd - device return status.Please document the shipment tracking number: n/a - please provide the source or name of person providing answers to follow-up questions: dr anish shah, customer 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 CHR UD 27IN 2-0 S/A CT-1
• 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: 18977735
• Report Number: 2210968-2024-03443
• Device Sequence Number: 6497729
• Product Code: GAL
• UDI-Device Identifier: 10705031012738
• UDI-Public: 10705031012738
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2024

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 811H
• Device Lot Number: RKMDAP
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 03/26/2024; 03/29/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 03/26/2024; 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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: Female