MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 36IN 0 D/A SH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	X524H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an ovarian torsion procedure on (b)(6) 2023 and suture was used.During the procedure, the head of nurses update that in ovarian torsion surgery that preformed week ago in the surgery the needle was broken while the surgeon try to straighten the needle.In order to finish the surgery, they open new suture.The surgery end successfully.No adverse patient consequences were reported.
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.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.Additional information was requested, and the following was obtained via: did the needle fall into the patient? if yes, was the needle piece removed from the patient during the same procedure? yes.Were x-rays taken to locate the needle? unknown.Was there any patient consequence or injury? no.What is the patient¿s current health status and condition? unknown.Was any other tissue damaged as a result of searching the needle? no.What measures were taken to retrieved the broken piece? unknown.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: EB EXC GRN 36IN 0 D/A SH
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17319844
• Report Number: 2210968-2023-05117
• Device Sequence Number: 20380365
• Product Code: GAT
• UDI-Device Identifier: 10705031057470
• UDI-Public: 10705031057470
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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 Expiration Date: 04/30/2026
• Device Model Number: X524H
• Device Catalogue Number: X524H
• Device Lot Number: REMACP
• 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: 06/23/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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: Unknown