MAUDE Adverse Event Report: ETHICON, INC. MONOCRYL; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y398
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Upon closure of peritoneum, ort noticed the sharpest end of the suture broke off.It was collected as well as the package.The circulator called the charge nurse to operating room.Collected and packaged the broken suture in entirety.No injury.Fda safety report id #(b)(4).

• Brand Name: MONOCRYL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 15674373
• Report Number: MW5112866
• Device Sequence Number: 14961635
• Product Code: GAN
• UDI-Device Identifier: 10705031059092
• UDI-Public: 10705031059092
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2022

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: Y398
• Device Catalogue Number: XJY398.P31
• Device Lot Number: SHMBBB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female