MAUDE Adverse Event Report: ETHICON INC. ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE; STAPLE, IMPLANTABLE

Catalog Number	STRAP25R
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.Attempts are being 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.H6 component code: g07002 ¿ device not returned.
Event or Problem Description
It was reported that a patient underwent a sacrocolpopexy procedure on an unknown date in 2024 and absorbable straps were used.The device was fired and the first 2 tackers were deployed as expected to anchor the mesh in place.However the third tacker which was deployed did not penetrate the tissue despite the nozzle of the device being flush with the tissue, thereafter the fourth firing did not deploy and the fifth deployed 2 tacks, both of which did not penetrate the tissue.The sixth firing deployed as expected until the mesh was secured however the surgeon remarked that there were 3-4 tacks wasted.The surgeon remarked that he is not used to this level of performance from the device.There was no delay in surgery.The straps were easily removed without additional intervention.There were no adverse patient consequences reported.No further information was provided.
Additional Manufacturer Narrative
(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.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.The lot number provided, tgmdrg, is invalid.Please confirm the lot number involved.Corrected information: d4 (catalog code & lot number).
Additional Manufacturer Narrative
(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.H3 analysis 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 determined that the strap25r device was returned without damages in the external components.In an attempt to replicate the reported incident, fire testing was not conducted because trigger was jammed.The instrument was disassembled; upon disassembly the prongs of the fork were deformed causing the jamming and fifteen(15) straps were found inside cannula shaft.  the event reported was confirmed and it is related to improper use of the device.A possible cause for the condition of the prongs of the fork deformed is indicative of the device being fired into bone or another hard surface, thus rendering device unusable.The instructions for use states that a minimum tissue thickness of 6.7 mm is required when applying the fastener over underlying bone, vessels, or viscera.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

• Brand Name: ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18885815
• Report Number: 2210968-2024-02900
• Device Sequence Number: 7605474
• Product Code: GDW
• UDI-Device Identifier: 10705031470552
• UDI-Public: 10705031470552
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,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: 05/31/2025
• Device Catalogue Number: STRAP25R
• Device Lot Number: TGMDRJ
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 05/29/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 05/20/2024; 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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