MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 1 S/A CTX; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z371T
Medical Device Problem Codes	Break (1069); Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2020
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.Additional information was requested and the following was obtained: please clarify what is the specific issue with the device during this procedure? bowel.Did the suture detach from the needle? no.Did the suture also break? yes.Where did the suture break? at some part in the middle of the suture.Did the suture only break at the point that it is attached to the needle? no the suture broke, it did not break directly at the needle attachment procedure date? (b)(6) 2021 the product was not returned to ethicon inc for evaluation.Visual inspection was conducted on the picture received.Visual analysis of the picture received determined that a foil packet of product code z371 could be observed.However, the reported conditions could not be observed in the picture.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.A manufacturing record evaluation was performed for the finished device batch qkmleh and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a low anterior resection procedure on (b)(6) 2021 and suture was used.During the procedure, the suture broke.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Date sent to the fda: 04/22/2021.Additional h3 summary: visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one needle/suture piece of product code z371 was received for evaluation, the swage and attachment area were noted to be as expected, the suture was noted with several damaged near of the swage area that appears to be by use of the surgical instrument.The end of the suture was noted with damaged, cut and stress caused by use, the surface of the suture has body fluids, fraying along of the strand due to use, manipulation and surgical instrument.The condition of the sample received indicate an improper handling of the device.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.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.Date sent to the fda: 04/22/2021.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.

• Brand Name: PDSII VIO 36IN 1 S/A CTX
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11477212
• Report Number: 2210968-2021-02312
• Device Sequence Number: 19740874
• Product Code: NEW
• UDI-Device Identifier: 10705031060821
• UDI-Public: 10705031060821
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2021

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 Expiration Date: 08/31/2025
• Device Model Number: Z371T
• Device Catalogue Number: Z371T
• Device Lot Number: QKMLEH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 03/25/2021; 04/22/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/22/2021; 05/17/2021
• Patient Sequence Number: 1