MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 8-0 D/A BV130-5 EP; SUTURES - NON-ABSORBABLE

Catalog Number	EP8732H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
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 lot, and no non-conformances were identified.H6 component code: g07002 device not returned.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.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts were 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.Additional information was requested, and the following was obtained: the sutures ware cut from the middle during surgery.- what does ".Were cut several time." mean? please provide additional details about this statement.They mean the incident repeated around 4 times in different procedure with the same suture code.- when did the alleged deficiency occurred (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? during tying.- how many devices demonstrated the alleged deficiency? please specify by product code and lot number.Description cat# lot# expiry account prolene 7/0 ep8732h thbamz 30-06-2028 prolene 8/0 ep8741h 103em0 31-08-2029.Prolene 8/0 ep8741h sdbdhl 31-03-2027.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture was cut several times.The procedure was completed successfully.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: PRLNE BLU 24IN 8-0 D/A BV130-5 EP
• Common Device Name: SUTURES - NON-ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22537492
• Report Number: 2210968-2025-08310
• Device Sequence Number: 7932481
• Product Code: GAW
• UDI-Device Identifier: 10705031215948
• UDI-Public: (01)10705031215948(17)280630(10)THBAMZ
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 07/17/2025

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: EP8732H
• Device Lot Number: THBAMZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2023
• 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