MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 9IN 4-0 S/A SH-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	SXPP1B454
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.Additional information was requested and the following was obtained: what tissue was being sutured when the event occurred? the stomach and esophagus.Was additional dissection required in other organs/tissues other than the target tissue? no further information is available.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? no further information is available.Was there any change in the patient¿s post-operative care due to the prolonged procedure? no further information is available.(b)(6).
Event or Problem Description
It was reported that a patient underwent a gastrectomy procedure on (b)(6) 2021 and barbed suture was used.During the procedure, it was reported by a sales rep that while suturing the stomach and esophagus by continuous suturing, the suture was detached from the needle, and the needle went into the body cavity.It took 3 hours to find the needle.In the end, it was hidden behind the spleen, and x-ray was taken 3 times.The operation time was extended about 180 minutes.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 5/18/2021.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 batch pkh775, and no non-conformances were identified.Additional h3 investigation summary: the product was returned for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one opened sample of product code sxpp1b454 was received for evaluation.The product code is single-armed and on the detached needle, the swage and attachment area was noted to be as expected, marks by the surgical instrument were noted and no suture remnant could be observed into the barrel hole.The suture was not received for evaluation to determine the assignable cause.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.No conclusion could be reached as to what caused the reported complaint.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.Trade name - irgacare®; active ingredient(s) ¿ triclosan; dosage form ¿ suture/solid/parenteral; strength ¿ = 2360 g/m.

• Brand Name: SFX SPI PDS+ UNI VIO 9IN 4-0 S/A SH-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11641083
• Report Number: 2210968-2021-03195
• Device Sequence Number: 2988185
• Product Code: NEW
• UDI-Device Identifier: 10705031240841
• UDI-Public: 10705031240841
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K182873
• 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,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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: 08/31/2021
• Device Model Number: SXPP1B454
• Device Catalogue Number: SXPP1B454
• Device Lot Number: PKH775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1