MAUDE Adverse Event Report: ETHICON INC. STRATAFIX; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B113
Medical Device Problem Code	Failure to Degrade (4084)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 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.The manufacturing records could not be reviewed as the batch/lot number is unknown.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.Additional information was requested, and the following was obtained via: what is the current status of the patient? discharged - do you have any photos available for visual analysis nonvisible ¿ what was the appearance of the suture during the removal , visble and hard to remove - if re-suture/re-closure was performed: n/a ¿ was reoperation necessary to remove the suture and re-close the wound? no product for return additional information received: i have a key customer who has experienced several cases where monocryl sutures have remained visible and prominent months after the procedure, requiring them to be cut out at a later stage.As a result of this, the surgeon has stopped using stratafix monocryl and has reverted to core monocryl.Given his experience, he would like to discuss this further with the r&d team to understand whether there have been any other reported instances.He suspects the barbed design may be contributing to the suture remaining in situ and not fully dissolving as expected.Any support or guidance on how best to progress this would be greatly appreciated, as this is a key customer for us.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and barbed suture was used.During the procedure, where the stratafix monocryl was still present after 4 months and had to be removed by surgeon.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: STRATAFIX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.; 1000 route 202; raritan 08869 0151
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25222826
• Report Number: 2210968-2026-05566
• Device Sequence Number: 13209611
• Product Code: GAM
• UDI-Device Identifier: 10705031236721
• UDI-Public: 10705031236721
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 05/19/2026

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 Catalogue Number: SXMP1B113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/19/2026
• 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
• Patient Sex: Unknown