MAUDE Adverse Event Report: ETHICON, LLC PDS; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	Z371T
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While the surgeon was suturing - the pointy part of the suture (lot: 106g3d - ref: z371t ) broke off - everyone was aware.X-ray was called and confirmed "no retained item".

• Brand Name: PDS
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON, LLC; 475 c street; los frailes industrial park, s; guaynabo PR 00969
• MDR Report Key: 22850178
• Report Number: 22850178
• Device Sequence Number: 8457793
• Product Code: NEW
• UDI-Device Identifier: 10705031060821
• UDI-Public: (01)10705031060821
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/14/2025
• Report Date (Section F): 08/14/2025

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: Z371T
• Device Catalogue Number: Z371T
• Device Lot Number: 108LK2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2025
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Date Report Sent to FDA: 08/14/2025