MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UD 5IN2 4-0 D/A PS2 PR MP; STRATAFIX SPIRAL MONOCRYL PLUS BIDIRECTIONAL KNOTLESS TISSUE CONTROL DEVICE

Catalog Number	SXMP2B407
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown general plastic combo procedure on an unknown date and barbed suture was used.In the middle of suturing the needle broke.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #:(b)(4).No device problem found additional information was requested, and the following was obtained: did the needle fall into the patient? no.The following information was requested, but unavailable: if yes, was the needle piece removed from the patient during the same procedure? n/a.Were x-rays taken to locate the needle? n/a.Was any other tissue damaged as a result of searching the needle? n/a.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the device.Visual analysis of the returned sample revealed that only one empty open foil packet was received that pertain to product code sxmp2b407.During visual inspection of the foil, it was noted that the needle or suture were not received for evaluation.Therefore, no conclusion could be reached on the cause of the reported event.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.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.

• Brand Name: SFX SPI MCRYL+ UD 5IN2 4-0 D/A PS2 PR MP
• Common Device Name: STRATAFIX SPIRAL MONOCRYL PLUS BIDIRECTIONAL KNOTLESS TISSUE CONTROL DEVICE
• 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 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15632392
• Report Number: 2210968-2022-08566
• Device Sequence Number: 17620137
• Product Code: GAM
• UDI-Device Identifier: 10705031464384
• UDI-Public: 10705031464384
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K192580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2022

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: 10/31/2023
• Device Catalogue Number: SXMP2B407
• Device Lot Number: RMBDBP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2021
• 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