MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 2-0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z339H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
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.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.What is the lot number? what is the status of the return sample?.
Event or Problem Description
It was reported that a patient underwent an open hiatal hernia procedure on (b)(6) 2021 and suture was used.During the procedure the suture broke.It is unknown what was being done at the time of the suture breakage.Another like device was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 9/21/2021.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Additional h3 investigation summary: visual analysis of the returned product revealed that one suture product code z339 was received to ethicon inc for evaluation.Upon visual inspection of the returned sample, the suture was received cutted, damages at the surface, in addition, the ends were observed with stress.After further evaluation crimping marks were observed on the surface suture possibly from a surgical instrument.The product code z339 contains absorbable suture, as the sample was received open, the time of exposed to the environment could not be determined and functional test cannot be performed.The manufacturing records couldn't be reviewed as the batch number is unknown.The condition of the sample received indicates improper handling of the device.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: PDSII VIO 27IN 2-0 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12353879
• Report Number: 2210968-2021-07592
• Device Sequence Number: 19711851
• Product Code: NEW
• UDI-Device Identifier: 10705031060609
• UDI-Public: 10705031060609
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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 Model Number: Z339H
• Device Catalogue Number: Z339H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/21/2021
• Patient Sequence Number: 1