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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a revision knee replacement surgery on (b)(6) 2022 and barbed suture was used.During the procedure, the barbed suture cut in half.The surgery was delayed due to this reported event by five minutes.The patient was sutured again.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (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.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 g/m.(b)(4).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.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.What was being done when the suture broke (removal from package / during passage through tissue / during tying / other )? what tissue was being approximated/ sutured? if breakage occurred during usage, how many tissue passes had occurred before breakage? approximate location of breakage on suture in relation to needle? what in the physicians opinion was the cause of the suture breakage? was the procedure completed successfully? **was there any adverse patient outcome? will the actual sample be returned for evaluation? are any representative samples available for evaluation? related medwatch reports: 2210968-2022-04505.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 07/14/2022.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.Additional information was requested and the following was obtained: what was being done when the suture broke (removal from package / during passage through tissue / during tying / other )? during passage through tissue.What tissue was being approximated/ sutured? subcutaneous.If breakage occurred during usage, how many tissue passes had occurred before breakage? 8 at least.Approximate location of breakage on suture in relation to needle? 10 cms from the needle.What in the physicians opinion was the cause of the suture breakage? deficiency of the suture.Was the procedure completed successfully? yes.Was there any adverse patient outcome? no.Will the actual sample be returned for evaluation? no.Are any representative samples available for evaluation? no.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 2360 g/m.Related medwatch reports: 2210968-2022-04504 and 2210968-2022-04505.

• 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; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 14675799
• Report Number: 2210968-2022-04504
• Device Sequence Number: 17302071
• Product Code: GAM
• UDI-Device Identifier: 10705031236448
• UDI-Public: 10705031236448
• Combination Product (Y/N): Y
• Initial Reporter Country: CI
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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 Model Number: SXMP1B410
• Device Catalogue Number: SXMP1B410
• Device Lot Number: RMBASE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown