MAUDE Adverse Event Report: ETHICON INC. PRLNE HS BLU 30IN 5-0 D/A C-1 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPH7477H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported that it is a recurrent issue: the needle loosened during use.This is a repetitive incident in the service, as this problem occurs almost every time there is an intervention.This detachment issue seems to be specific to this reference, which replaces the one usually used in the service.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/17/2025.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, or its employees that the report constitutes an admission that the product, ethicon, 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.Additional information was requested, the following was obtained: how many devices demonstrated the alleged deficiency? for the case (b)(4): one for the recurring see note a-12879248 what is the total number of procedures involved? see note a-12879248 have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? see note a-12879248 can you tell us how long you have been experiencing this issue and the affected lot? since mid-2024 do you have the declaration of the other impacted procedures? unfortunately, not, but we had already declared the same problem: june 2024: (b)(4).End of december 2024: (b)(4).For the unreported case the (b)(4).Has been opened (recurring issue) 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.

• Brand Name: PRLNE HS BLU 30IN 5-0 D/A C-1 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• 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: 21859565
• Report Number: 2210968-2025-04125
• Device Sequence Number: 7916851
• Product Code: GAW
• UDI-Device Identifier: 10705031233454
• UDI-Public: (01)10705031233454(17)290731(10)102M90
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2025

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: EPH7477H
• Device Lot Number: 102M90
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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