MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 60IN 2-0 S/A CTX LP; SUTURE, SURGICAL, ABSORBABLE

Model Number	D8588
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that the patient underwent a c-section procedure on unknown date and the suture was used.It was reported that the suture rupture/breakage occurred there were no patient consequences reported.
Additional Manufacturer Narrative
Date sent to the fda: 02/28/2020.Corrected b5 narrative: it was reported that the patient underwent a c-section surgery on (b)(6) 2020 and the suture was used.During the procedure, the tip of the needle broke while suturing, unknown layer of tissue, unknown loop.The needle tip was removed from the patient.The procedure was completed using unknown suture.There were no patient consequences reported.

• Brand Name: PDSII VIO 60IN 2-0 S/A CTX LP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9767845
• Report Number: 2210968-2020-01597
• Device Sequence Number: 3308169
• Product Code: NEW
• UDI-Device Identifier: 10705031030626
• UDI-Public: 10705031030626
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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 Model Number: D8588
• Device Catalogue Number: D8588
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 02/28/2020
• Patient Sequence Number: 1