MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 0 S/A CT; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z358T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 following information was requested, but unavailable: what tissue was being approximated or sutured when it broke? what was used to complete the procedure? did the patient experience any adverse consequences due to this issue? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a urological procedure on (b)(6) 2020 and suture was used.During the procedure, the suture is easily broken when tying a knot.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDSII VIO 36IN 0 S/A CT
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11779655
• Report Number: 2210968-2021-04214
• Device Sequence Number: 3946258
• Product Code: NEW
• UDI-Device Identifier: 10705031060760
• UDI-Public: 10705031060760
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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 Expiration Date: 07/31/2024
• Device Model Number: Z358T
• Device Catalogue Number: Z358T
• Device Lot Number: PJ5372
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1