MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 36IN 1 S/A CTX; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP371T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pek836 batch number, and no non-conformance's were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.What tissue was being approximated or sutured when it broke? what was the name of the procedure? what was used to complete the procedure? this medwatch report is in response to receipt of voluntary report mw# (b)(4).
Event or Problem Description
It was reported that the patient underwent an unknown surgery on (b)(6) 2019 and the suture was used.During the surgery, the suture broke when tying it.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 3/6/2020.Additional information was requested and the following was obtained: what tissue was being approximated or sutured when it broke? - fascis.What was the name of the procedure? - c/s.What was used to complete the procedure? - suture.

• Brand Name: PDS+ VIO 36IN 1 S/A CTX
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9684856
• Report Number: 2210968-2020-01038
• Device Sequence Number: 16927803
• Product Code: NEW
• UDI-Device Identifier: 10705031048201
• UDI-Public: 10705031048201
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: PDP371T
• Device Catalogue Number: PDP371T
• Device Lot Number: PEK836
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1