MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 4-0 S/A SH-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z310H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
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: were there any patient consequences? there were no adverse consequences to the patient.The following information was requested, but unavailable: how was the procedure completed? no further information is available.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 a nephrectomy on (b)(6) 2020 and suture was used.When trying to use the needle-suture, the suture was detached from the needle.It was not a control release needle.Lot number - qcmlta - unknown if this is the correct lot number.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 03/03/2021.Additional information: d9, h6.Additional h3 investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that one opened sample of product code z310 was received for evaluation.Short insertion could be observed in the strand.The visual inspection concluded that the was detached from the needle, since the insertion end of the suture did not meet the requirement.This defect is caused because the insertion of the suture in the needle was insufficient from keep the needle/suture union during transportation or use, resulting in a pull-out defect.The pull-out defect has been correlated to the manufacturing process.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.Based on the information currently available, the pull-out was identified during the investigation of the sample received.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 27IN 4-0 S/A SH-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11139574
• Report Number: 2210968-2021-00159
• Device Sequence Number: 4051292
• Product Code: NEW
• UDI-Device Identifier: 10705031060418
• UDI-Public: 10705031060418
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 12/15/2020

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: 02/28/2025
• Device Model Number: Z310H
• Device Catalogue Number: Z310H
• Device Lot Number: QCMLTA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 03/03/2021
• Patient Sequence Number: 1