MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 12INX3/16IN D/A CTX; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	RS22
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cervical cerclage under laparoscopy on (b)(6) 2025 and suture was used.It was reported that the problem of pulling off suture needle happened when sewing during the surgery.The needle did not fall into the patient.Changed another one to complete the surgery.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 8/21/2025 h6 component code: g07002 - no device problem found.H6 component code: c22 - photo analysis.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: it was reported that the event date is june 07, 2025, and the alert date is (b)(6) 2025.Could you please provide a justification for this variance in the timing of the report related to this file? loc just received the complaint from hospital in (b)(6) 2025.H3 investigational summary: the product was returned to ethicon for evaluation.One empty overwrap packet, one detached needle and one suture were received for analysis.Product code rs22.The visual assessment of the needle noted that the closure channel was observed to be as expected.The barrel hole was examined under magnification, and body fluids were found.In addition, the suture was examined, and the insertion mark was noted to be as expected.Given the current condition of the returned sample, it is not possible to determine the potential cause of the reported event.A photo was provided showing a plastic bag with an used detached needle, one suture and one overwrap packet that pertains to product code rs22.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.No conclusion could be reached on the cause of the reported event.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: MERS TAPE WHT 12INX3/16IN D/A CTX
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 22860316
• Report Number: 2210968-2025-09566
• Device Sequence Number: 7733330
• Product Code: GAT
• UDI-Device Identifier: 10705031049802
• UDI-Public: (01)10705031049802(17)270630(10)SHBDZD
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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: RS22
• Device Lot Number: SHBDZD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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