MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z346H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.    the suture is not available for analysis.The suture was discarded.If further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2020 and the suture was used.During surgery, when tying the knot, the pds suture broke twice.As a result, there was a surgery delay of 15 minutes.A like device was used to successfully complete the procedure.There were no fragments generated.There were no adverse patient consequences reported.

• Brand Name: PDSII VIO 36IN 0 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11168446
• Report Number: 2210968-2021-00333
• Device Sequence Number: 3966643
• Product Code: NEW
• UDI-Device Identifier: 10705031060661
• UDI-Public: 10705031060661
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 12/18/2020

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: 04/30/2025
• Device Model Number: Z346H
• Device Catalogue Number: Z346H
• Device Lot Number: QEMJRE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 01/13/2021
• Patient Sequence Number: 1