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

Model Number	SXMP2B408
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Suture frayed and broke during skin closure.Stratafix¿ spiral monocryl® plus suture.Ref: sxmp2b408, lot: ucbbzl, gtin: (b)(4).Exp: 02-28-2026.

• Brand Name: STRATAFIX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, LLC; 1000 us highway 202 s.; raritan NJ 08869
• MDR Report Key: 20841923
• Report Number: 20841923
• Device Sequence Number: 8152195
• Product Code: GAM
• UDI-Device Identifier: 10705031464315
• UDI-Public: (01)10705031464315
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2024
• Report Date (Section F): 12/02/2024

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: SXMP2B408
• Device Catalogue Number: SXMP2B408
• Device Lot Number: UCBBZL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/02/2024