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

Catalog Number	Z353H
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2017
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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? no piece fell on the patient.Was there any adverse patient consequence? if so, please provide detail for any medical or surgical intervention.There was no adverse consequence to the patient.
Event or Problem Description
It was reported that a patient underwent abdominal lipectomy procedure on (b)(6) 2017 and suture was used.The thread of the needle was disassembled (pulled off) during knotting.There were no adverse consequences to the patient reported.

• 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: 7461201
• Report Number: 2210968-2018-72346
• Device Sequence Number: 13739808
• Product Code: NEW
• UDI-Device Identifier: 10705031060722
• UDI-Public: 10705031060722
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 04/03/2018

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: 01/31/2021
• Device Catalogue Number: Z353H
• Device Lot Number: KBK599
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 66