MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 8X18IN 0 S/A CTB-1 CR; SUTURE, SURGICAL, ABSORBABLE

Model Number	ZB740
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.Additional information was requested and the following was obtained: please clarify, how many devices were involved in this single procedure =>the sales rep reported 3 needle-sutures.Procedure name and date: the procedure name is unknown.The procedure date is (b)(6) 2020.Status of product return: we regularly contact with sales rep about the device returning.No further information will be provided.Note: events reported in medwatch reports 2210968-2020-05005, 2210968-2020-05006, and 2210968-2020-05007.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2020 and suture was used.During wound closure by interrupted suturing, after passing the needle through the abdominal fascia, when trying to tie a knot, the suture was broken easily.Another package was used.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 07/29/2020 additional information: h4, h6 - method codes this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PDSII VIO 8X18IN 0 S/A CTB-1 CR
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10217489
• Report Number: 2210968-2020-05007
• Device Sequence Number: 16961760
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020

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: 08/31/2022
• Device Model Number: ZB740
• Device Catalogue Number: ZB740
• Device Lot Number: LKM087
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/29/2020
• Patient Sequence Number: 1