MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN USP4-0; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z924H
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).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 mjz006 number, and no non-conformances were identified.Additional information was requested and the following was obtained: were there any unexpected outcomes or complications as a result of the prolonged surgery time? no further information is available.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain: no further information is available.No further information will be provided.Note: event reported via mw 2210968-2019-82856 and 210968-2019-82857.
Event or Problem Description
It was reported that the patient underwent an unknown otolaryngology head and neck surgery on an unknown date and suture was used.During the procedure, the needle was detached from the suture during use.It was not a control release needle.The operation time was extended within 30 minutes.There were no adverse consequences to the patient.

• Brand Name: PDSII VIO 27IN USP4-0
• 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: 8708319
• Report Number: 2210968-2019-82856
• Device Sequence Number: 2268393
• Product Code: NEW
• UDI-Device Identifier: 10705031114777
• UDI-Public: 10705031114777
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

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: 07/31/2023
• Device Catalogue Number: Z924H
• Device Lot Number: MJZ006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/18/2019
• Patient Sequence Number: 1