MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 5-0 S/A PC-1 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	1855G
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 in 2025 and suture was used.During the procedure, it was reported by the distributor that the costumer using 5-0 nylon and the needle keeps popping off.It happened to the multiple doctors and just being connected that they are all have the same lot number.Unknown number of devices available for return.There were no adverse reported.Additional information was requested.
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.Additional information was requested, and the following was obtained via: - what is the total number of procedures? unknown - have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? i don¿t believe so _ h please confirm - if this event occurred during multiple procedures, please create a product complaint for each event and provide the corresponding reference number(s).Unknown.Boxes of sutures given to me with notes from other nurses or surgeons that is occurred with the lot.- when did the needle pulled-off occur (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? during suturing - how many devices demonstrated the alleged deficiency? 10 boxes - please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.Awaiting direction on what to do with affected product - provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).(please refer the attached email).

• Brand Name: ETHLN BLK 18IN 5-0 S/A PC-1 PRM MP
• 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: 22116933
• Report Number: 2210968-2025-06068
• Device Sequence Number: 4251122
• Product Code: GAR
• UDI-Device Identifier: 10705031002777
• UDI-Public: (01)10705031002777(17)290930(10)103SL6
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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: 1855G
• Device Lot Number: 103SL6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2024
• 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