MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 12INX3/16IN D/A BP-1; CLASS I DEVICE - EXEMPT

Catalog Number	RS21
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cervical cerclage surgery on (b)(6) 2025 and suture was used.During the procedure, at around 12:00, the operating room doctor performed a surgery using a suture tape.After checking for any abnormalities, the operation was carried out normally.However, during the surgery, the problem of pulling off suture needle happened, causing the surgery to be interrupted.The sutured suture tape must not be removed, and the needle and suture must be replaced to perform the surgery again.No adverse patient consequences were 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.The following information was requested, but unavailable: did this issue contribute to any patient adverse event? received information as following from sales rep via phone today.Please refer to the event description, other information requested is unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/13/2025.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.H6 component code: g07002 no device problem found corrected information: d4 udi additional information: d9, h3, h6 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.One used detached needle and one used needle suture combination were received for analysis.The product code rs21 is double armed.Upon visual inspection of the detached needle, the swage and attachment area were noted to be as expected.The barrel hole was examined under magnification, and no suture remnant was noted.The force used to detach the needle from the suture could not be determined.In addition, the needle suture was visually inspected, and the swage and attachment area was noted to be as expected.The suture was examined along the strand, and the insertion mark could be observed at the other extreme.A functional test was performed using instron equipment and the pull force was above the minimum requirements.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.No conclusion could be reached as to what caused the reported complaint.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: MERS TAPE WHT 12INX3/16IN D/A BP-1
• Common Device Name: CLASS I DEVICE - EXEMPT
• 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
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23222732
• Report Number: 2210968-2025-11393
• Device Sequence Number: 9648663
• Product Code: KDC
• UDI-Device Identifier: 10705031049789
• UDI-Public: (01)10705031049789(17)291130(10)105D3Z
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

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: RS21
• Device Lot Number: 105D3Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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