MAUDE Adverse Event Report: ETHICON INC. ETHICON SECURESTRAP; STAPLE, IMPLANTABLE

Catalog Number	STRAP12
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent hernia repair on (b)(6) 2025 and absorbable straps were used.The device was not performing.The trigger worked but pins didn't adhered to tissue, in between only 4 pins adhered.There was no patient adverse event.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.Additional information was requested and the following was provided: did this issue contribute to any patient adverse event? there was no patient adverse event.Please clarify, what was the issue experienced.The trigger worked but pins didn¿t adhered to tissue, in between only 4 pins adhered.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.
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.Additional information: d9, h3, h6.H3 investigation summary- the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the strap12 device was returned with the cannula shaft bent.In an attempt to replicate the reported incident, fire testing was not conducted because device found that it was returned with the cannula shaft bent.The instrument was disassembled; upon disassembly one(1) straps were found inside cannula shaft.The event reported was confirmed and it is related to improper use of the device.As per instrument condition, seems that the device was mishandled (application of excessive force) at an unknown point and the cannula was damaged.As part of ethicon¿s 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: ETHICON SECURESTRAP
• Common Device Name: STAPLE, IMPLANTABLE
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22913495
• Report Number: 2210968-2025-09928
• Device Sequence Number: 9184561
• Product Code: GDW
• UDI-Device Identifier: 10705031132986
• UDI-Public: (01)10705031132986(17)260930(10)104DU2
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093845
• 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,Followup

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 Expiration Date: 09/30/2026
• Device Catalogue Number: STRAP12
• Device Lot Number: 104DU2
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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