MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 8-18"(45CM) 0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	ZB740
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts are being 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.
Event or Problem Description
It was reported that the patient underwent laparoscopy-assisted distal gastrectomy on (b)(6) 2019 and suture was used.When closing wound of small incision site, one of the needles was detached from the suture easily during passing the needle through the fascia by interrupted suturing.It was a control release needle.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).The actual sample was returned for evaluation.An empty opened foil, a detached needle and a suture of product code zb740, lot ml5844 were returned for analysis.During the visual inspection of the needle, the swage and attachment area were as expected and remnant of the suture was noted into the barrel hole and slightly marks were observed on the edge of the needle that appears to be by the use of a surgical instrument.The dispensed suture was examined along of the strand and no defects were observed.However, the end of the suture is severely damaged appears to be by the use of a surgical instrument.Per the sample condition the assignable cause suggests an improper handling of the sample.

• Brand Name: PDS II SUTURE 8-18"(45CM) 0 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: 8363844
• Report Number: 2210968-2019-79022
• Device Sequence Number: 19322463
• Product Code: NEW
• UDI-Device Identifier: 10705031062108
• UDI-Public: 10705031062108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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: 09/30/2023
• Device Catalogue Number: ZB740
• Device Lot Number: ML5844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 03/21/2019
• Patient Sequence Number: 1