MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 4-0 S/A FS-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z397H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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.A manufacturing record evaluation was performed for the finished device mcm780 batch number, and no non-conformances related to the reported complaint condition were identified.Additional device same code reported in 2210968-2019-85759.
Event or Problem Description
It was reported that an animal underwent an unknown procedure on unknown date and suture was used.The needles came off of suture during use.It is unknown if a similar device was used or if it was completed successfully.There were no adverse patient consequences reported.

• Brand Name: PDSII VIO 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8907218
• Report Number: 2210968-2019-85758
• Device Sequence Number: 2731219
• Product Code: NEW
• UDI-Device Identifier: 10705031060838
• UDI-Public: 10705031060838
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

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: 02/28/2023
• Device Catalogue Number: Z397H
• Device Lot Number: MCM780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/19/2019
• Patient Sequence Number: 1