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

Catalog Number	Z304H
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/21/2024.H6 component code: g07002 - pending evaluation of returned device.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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: the event describes damage to the primary package.The additional information indicates sterility was compromised.Please explain.Was the suture tray/seal observed to be damaged within the crushed primary packaging? was there a hole or tear in the seal of the suture tray packaging? was the suture tray packaging intact within the crushed primary packaging? additional information was requested, the following was obtained: please provide photos of the compromised packaging please see pic below.Which part of the packaging was damaged: shipping box, internal packaging, etc.? shipping box and internal packaging.Do you believe this is a result of damage during shipping, or a manufacturing error? shipping.Is the sterility of the device compromised? yes.Status of product return.We are waiting for return labels.Sorry for the delay we don¿t usually have fedex arriving at our facility on a daily basis, we will try to have this shipped out today.A device has been received, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported by the account contact that on (b)(6) 2024 when their order was delivered via old dominion that the outside shipping box and the inside suture boxes were crushed.Box was on a pallet with the rest of their order.There was no procedure or patient involvement.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/20/2024 additional information: h3, h6 h3 investigational summary: the product was returned to ethicon for evaluation.Two opened boxes were received for analysis.Upon visual analysis of the complaint samples, it was observed that one side in both boxes were noted damaged/crushed.The packets inside were observed to be intact.Due to the damages found on the device, the complaint is confirmed, a possible cause for these conditions appears to be improper handling during transit or storage.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.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional information was requested, the following was obtained: the event describes damage to the primary package.Yes the additional information indicates sterility was compromised.Please explain.Yes, please see pic below.Was the suture tray/seal observed to be damaged within the crushed primary packaging? yes was there a hole or tear in the seal of the suture tray packaging? yes.Was the suture tray packaging intact within the crushed primary packaging? no.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 RB-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20746881
• Report Number: 2210968-2024-12270
• Device Sequence Number: 8377511
• Product Code: NEW
• UDI-Device Identifier: 10705031060371
• UDI-Public: (01)10705031060371(17)290531(10)101JMB
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2024

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 Catalogue Number: Z304H
• Device Lot Number: 101JMB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown