MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EP8714H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The patient has a retained needle in the abdomen.Additional information was requested.
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.(b)(4).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.Did the needle break during the initial procedure? did the needle pull off the thread during the initial procedure? is the whole needle retained in the patient¿s abdomen? or is a piece of a broken needle retained in the patient¿s abdomen? what was the size of the needle used? is more than half the needle retained in the patient? what is the size of the broken needle fragment? where is the needle retained; in what structure? are there plans to remove the retained needle/needle piece? what instruments were used to grasp the needle during the initial procedure? where was the needle grasped during use? were there any patient consequences due to the retained needle? are there plans for removal of any remaining needle fragments? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? please describe any medical/surgical intervention required for this retained needle event including dates and results.Other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to the broken needle/pull off event? what is the patient's current status? lot number for the prolene suture? if applicable, will product be returned? if so, please provide the return date and tracking information.Surgeon¿s name?.

• Brand Name: PROLENE SUTURE 18"(45CM) 6-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16233491
• Report Number: 2210968-2023-00478
• Device Sequence Number: 15196643
• Product Code: GAW
• UDI-Device Identifier: 10705031231245
• UDI-Public: 10705031231245
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K133356
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EP8714H
• Device Catalogue Number: EP8714H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown