MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 12INX3/16IN S/A MO-4; CLASS I DEVICE - EXEMPT

Catalog Number	RS23
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
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.H6 component code: g07002 device not returned.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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: were there any patient consequences? needle left in patient.What is the event/procedure date (dd/mm/yyyy)? (b)(6) 2024.Attempts are being 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.Did 1 or 2 patients experience needle breaking off during a cervical cerclage? please create an additional complaint file if 2 different patients experienced this issue.How many devices had this issue for each patient? clarify if the event is needle pull off or a needle breakage? what instruments were used to grasp the needle/suture? where was the needle/suture grasped during use? were x-rays performed to localize the needle fragment? what was the size of the broken needle fragment? were the needle piece(s) retrieved during the same procedure? does the piece/device remain retained in the patient's tissue? if the piece(s) were retained, where are they located/in what structure? if retained, were there any patient consequences? if retained, are there plans for removal of any remaining fragments? if yes, please describe.Did the patient experience any adverse patient consequences?.
Event or Problem Description
It was reported that a patient underwent a cervical cerclage procedure on (b)(6) 2024 and suture was used.The needle broke off during the procedure.Additional information was requested.
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.The following information was requested, but unavailable: please create an additional complaint file if 2 different patients experienced this issue.How many devices had this issue for each patient? clarify if the event is needle pull off or a needle breakage? what instruments were used to grasp the needle/suture? where was the needle/suture grasped during use? were x-rays performed to localize the needle fragment? what was the size of the broken needle fragment? were the needle piece(s) retrieved during the same procedure? does the piece/device remain retained in the patient's tissue? if the piece(s) were retained, where are they located/in what structure? if retained, were there any patient consequences? if retained, are there plans for removal of any remaining fragments? if yes, please describe.Did the patient experience any adverse patient consequences?.

• Brand Name: MERS TAPE WHT 12INX3/16IN S/A MO-4
• Common Device Name: CLASS I DEVICE - EXEMPT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19996474
• Report Number: 2210968-2024-08581
• Device Sequence Number: 18233404
• Product Code: KDC
• UDI-Device Identifier: 10705031049826
• UDI-Public: (01)10705031049826(11)231106(17)281031(10)TMMCAZ
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: RS23
• Device Lot Number: TMMCAZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2023
• 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