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

Model Number	Z371T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported in 2210968-2021-06254 and 2210968-2021-06255.
Event or Problem Description
It was reported that a patient underwent an open ventral hernia procedure on (b)(6) 2021 and suture was used.During the procedure, the suture strands broke midway while tying a knot.Another like device was used to complete the procedure.No adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 07/29/2021 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 information: d9 investigation summary : according to the information received, while tying a knot the suture strands broke midway during interrupted suturing.Visual analysis of the returned product revealed that one empty opened foil and a needle/suture piece product code z371 were received to ethicon inc for evaluation.Upon visual inspection of the returned sample, the suture was damaged at the surface, in addition, the end was observed cut.After further evaluation crimping marks were observed on the surface of the suture possibly from a surgical instrument.The product code z371 contains an absorbable suture.As the package was received open, the time of exposure to the environment could not be determined and a functional test could not be performed.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.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• 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 08869
• MDR Report Key: 12157791
• Report Number: 2210968-2021-06254
• Device Sequence Number: 3801137
• Product Code: NEW
• UDI-Device Identifier: 10705031060821
• UDI-Public: 10705031060821
• 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): 06/17/2021

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: 12/31/2025
• Device Model Number: Z371T
• Device Catalogue Number: Z371T
• Device Lot Number: RAMMKJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1