MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+UNI VIO 6IN 2-0 S/A CT-2; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B443
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	03/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a prostatectomy on (b)(6) 2025 and a barbed suture was used.Post-op, the suture came apart causing a leak.The patient was readmitted.The patient was over sewed.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6 component code: g07002 device not returned 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.Three different product codes for stratafix spiral monocryl plus were reported: were all 3 sutures of the different spiral monocryl plus product codes used in the patient? or was 1 stratafix spiral monocryl plus suture used and the product code was unknown and sxmp1b443, sxmp1b449, and sxmp1b424 are possible product codes? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was each suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? was the fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? what instruments were used in this procedure to handle the suture? please describe any medical/surgical intervention required for this suture event including dates and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? please describe where the leak was noted? were all 3 sutures used at the site of the leak? did all 3 suture of product codes sxmp1b443, sxmp1b449, and sxmp1b42 come apart? please specify.Please describe further details of what is meant by ¿the suture came apart¿.Did each stratafix suture break post-op? if so, where was the break noted (termination, middle, end)? can you describe the appearance of each stratafix suture during second procedure? were there any precipitating patient stress factors for the sutures untying, breakage or pulling out of the tissue? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? lot number for suture of product code sxmp1b443? lot number for suture of product code sxmp1b449? lot number for suture of product code sxmp1b424?.
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.Additional information: d4 primary udi number.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information was requested, and the following was obtained: response from sales rep stating that all information known at this time has been provided.

• Brand Name: SFX SPI MCRYL+UNI VIO 6IN 2-0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC 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 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 21784248
• Report Number: 2210968-2025-03624
• Device Sequence Number: 12941754
• Product Code: GAM
• UDI-Device Identifier: 10705031469976
• UDI-Public: 10705031469976
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221744
• 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,Followup
• Report Date (Section B): 05/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SXMP1B443
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown