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	05/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent laparoscopic incisional hernia repair surgery on (b)(6) 2024 and absorbable straps were used.The device could not fire.When the doctor used the fixation device to fix the patch during surgery, the third or fourth straps could not be effectively inserted, but it was taken out of the abdominal cavity and attempted to be fired externally, but it was also powerless.Changed to another one to complete the surgery.There were no adverse patient consequences reported.No additional information could be 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.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 revealed that the strap25r device was returned with no damage in the external components.One strap and a suture piece were returned inside a plastic bag.In addition, a foil pouch was received.In an attempt to replicate the reported incident, fire testing was not conducted because trigger was jammed.The instrument was disassembled; upon disassembly the ratchet pawl component was found excessive wear and tear.Seventeen (17) straps were found inside cannula shaft.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what may have caused the reported incident.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: 19559003
• Report Number: 2210968-2024-06333
• Device Sequence Number: 4734780
• Product Code: GDW
• UDI-Device Identifier: 10705031470552
• UDI-Public: 10705031470552
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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

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: 12/31/2024
• Device Catalogue Number: STRAP25R
• Device Lot Number: TAMEUM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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 Age: 69 YR
• Patient Sex: Male