MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 27"(70CM) 3-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z305H
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.When was it noticed the swaged suture pulling off the needle? before use on patient - while in package noticed upon opening / upon dispensing? or during use on patient - while suturing? total qty involved with the suture-needle pull off? was procedure completed successfully? and how? it is mentioned in the report " trouble in the past with swaged suture pulling off the needle", were these cases previously reported? if yes, provide the reference numbers? if not, can you provide the total number of procedures/patient events where this issue was noticed? for each procedure provide: a.Event description b.Product code and lot number c.Event date d.Procedure name e.Patient consequences/ae report if any? f.Qty involved? g.Sample return, if any?.
Event or Problem Description
It was reported that animal underwent unknown procedure on unknown date and suture was used.The suture pulled off the needle.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda.2/7/2018 additional information was requested and the following was obtained: when was it noticed the swaged suture pulling off the needle? before use on patient - while in package noticed upon opening / upon dispensing? or during use on patient - while suturing? during use, while suturing.Was procedure completed successfully? and how? yes, used a new package of suture material.

• Brand Name: PDS II SUTURE 27"(70CM) 3-0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7231102
• Report Number: 2210968-2018-70563
• Device Sequence Number: 19196265
• Product Code: NEW
• UDI-Device Identifier: 10705031060395
• UDI-Public: 10705031060395
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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: 11/30/2021
• Device Catalogue Number: Z305H
• Device Lot Number: KPM119
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1