MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 27"(70CM) 1 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z341H
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.1.The reported quantity involved was 11.Did 11 sutures disconnect from the needle during one patient procedure? if not, please provide the following information: a.How many patient procedures did the doctor experience the suture pulling off from the needle? b.What is the quantity of sutures that pulled off the needle, per patient procedure? c.What was the name and date of each patient procedure? d.Did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? e.When did the needle pull off (while in the package / during dispensing / during preparation / during use)?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2017 and suture was used.During use the suture disconnected from the thread.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: PDS II SUTURE 27"(70CM) 1 VIO
• 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: 7300127
• Report Number: 2210968-2018-71072
• Device Sequence Number: 1823526
• Product Code: NEW
• UDI-Device Identifier: 10705031060647
• UDI-Public: 10705031060647
• Combination Product (Y/N): N
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2018

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: 12/31/2021
• Device Catalogue Number: Z341H
• Device Lot Number: LAZ472
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1