MAUDE Adverse Event Report: ETHICON INC. STFX SPI MCRYL+ UNI 12IN 2-0 UD; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Model Number	SXMP1B410
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Discomfort (2330)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.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.Were there any alleged deficiencies noted with the device that could have contributed to the patient¿s post-operative complications as mentioned in the event description? were there any treatments given to the patient were prescribed or just routine cleaning? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; drainage)? if so, please specify.Was there was a prescription for steroids or antibiotics for the patient's recovery? if yes, please provide medication name, route and dose.Was dehiscence noted.Photo analysis summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows an apparent section of a suture.Based on the photo review, no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Component code: g07002 ¿ device not returned.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.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 an unknown procedure on an unknown date and barbed suture was used.On (b)(6) 2023, when visiting an outpatient clinic after surgery, the patient feels pain and discomfort due to discomfort in the surgical area.Inflammation was also experienced.Some parts of the suture were not absorbed and removed.70 days have passed since the surgery.Additional information has been requested.

• Brand Name: STFX SPI MCRYL+ UNI 12IN 2-0 UD
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16742460
• Report Number: 2210968-2023-02724
• Device Sequence Number: 6539503
• Product Code: GAM
• UDI-Device Identifier: 10705031236448
• UDI-Public: 10705031236448
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,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: 09/30/2024
• Device Model Number: SXMP1B410
• Device Catalogue Number: SXMP1B410
• Device Lot Number: SLBAAP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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