MAUDE Adverse Event Report: ETHICON INC. STFX SPI PDS+ UNI VIO 18IN 2 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B430
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 obtained: were there any unexpected outcomes or complications as a result of the prolonged surgery time? no further information is available.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain: no further information is available.Please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.We regularly contact with sales rep about the device returning.No further information will be provided.Lot number: unknown: rgbcdr.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 this is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare active ingredient(s)- triclosan dosage form - suture/solid/parenteral strength - = 2360 ¿g /m.
Event or Problem Description
It was reported that a patient underwent a laparoscopic myomectomy on (b)(6) 2021 and suture was used.During the procedure, the suture was broken during suturing on the myometrium.Before the suture was broken, hemostasis was performed using a bipolar.The operation time was extended within 30 minutes.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/2/2022.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational narrative: the product was returned to ethicon inc for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that an empty labeled winding former and one needle/suture piece of product code sxpp1b430 were received for evaluation, the swage and attachment area was noted to be as expected, the suture piece was observed with body fluids and marks on the surface and was cut appears to be by use of the surgical instrument.The product code sxpp1b430 contains absorbable suture and as the sample was received open, the time of exposure of suture to the environment could not be determined and no functional test can be performed due to sample condition.The condition of the sample received indicates improper handling of the device.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Trade name - irgacare.Active ingredient(s)- triclosan.Dosage form - suture/solid/parenteral.Strength - = 2360 g /m.

• Brand Name: STFX SPI PDS+ UNI VIO 18IN 2 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13111612
• Report Number: 2210968-2021-13025
• Device Sequence Number: 17264308
• Product Code: NEW
• UDI-Device Identifier: 10705031235823
• UDI-Public: 10705031235823
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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: 05/31/2023
• Device Model Number: SXPP1B430
• Device Catalogue Number: SXPP1B430
• Device Lot Number: RGBCDR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• 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