MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UNI UD 6IN 3-0 S/A RB-1; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Model Number	SXMP1B424
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint number: (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: please clarify: did the fixation feature (loop or tab) broke during the procedure? or did the suture break during the procedure? the loop and tab were ok.But suture¿s body break during the procedure.What tissue was being approximated/ sutured? procedure name and date? event date? transoral thyroidectomy on 2022/3/7, suture break when surgeon closed the wound after remove thyroid sample.Lot number? unknown.Device return status? the device is under return process from customer.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 - stratafix¿, 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 transoral thyroidectomy on (b)(6) 2022 and barbed suture was used.During the procedure, the suture body broke.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/22/2022.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.H3 investigational summary: upon visual inspection of the needle-suture piece, the suture was observed with damaged at the surface and the end of the suture cut.After further evaluation body fluids and crimping marks were observed on the surface suture possibly from a surgical instrument.The event reported was confirmed and it is related to improper use of the device.Please reference the instruction for use.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.The manufacturing records couldn¿t be reviewed as the lot number is unknown.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Trade name - stratafix¿; active ingredient(s)- triclosan; dosage form - suture/solid/parenteral; strength - = 2360 g /m.

• Brand Name: SFX SPI MCRYL+ UNI UD 6IN 3-0 S/A RB-1
• 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 PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14163968
• Report Number: 2210968-2022-02816
• Device Sequence Number: 11474577
• Product Code: GAM
• UDI-Device Identifier: 10705031236509
• UDI-Public: 10705031236509
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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 Model Number: SXMP1B424
• Device Catalogue Number: SXMP1B424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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