MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 3-0 S/A RB-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z305H
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that a patient underwent an unknown surgery on an unknown date.And suture was used.During the procedure when opening the package, it was found that there was a thick suture in the package, so the product was not used.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).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.H6 component code: g07002.Device not returned.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.Related medwatch reports: 2210968-2023-03117.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/19/2023.H6 component code: g07002 no device problem found.Additional information was requested, the following was obtained: 1.Could you please clarify if the additional device belong to this complaint? yes.Lot shmdju was opened by the customer to compare sutures between shmhks and shmdju.So both packs were returned belong to this complaint.1a.If yes, did a device malfunction occur during the same procedure? no.2.If not, could you please clarify if the additional received product belongs to a different complaint? no if so, can you please provide the complaint number: na.3.If the device was not reported before, please provide more details of device malfunction.Na.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.Please discard.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to (b)(6) with the ups, dhl or fedex tracker number: (b)(4).I certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted in ecm note.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned samples determined that it was received, one opened sample that pertain to product code z305h.In order to evaluate the condition of the returned sample, the swage and attachment area was noted to be as expected.The suture was dispensed without problems and examined along the strand no anomalies were observed during the evaluation.In addition, the suture was measured, and the results met with the requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.Related reports: 2210968-2023-03117.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/24/2023.H6 component code: g07002 - pending evaluation of returned device.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.A device has been received for product code z305h, lot shmhks, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A device has been received for product code z305h, lot shmdju, however clarification is requested whether the product belongs to this complaint.Our failure analysis lab received the additional product with reference to this complaint, the following product was received: -product code z305h, lot shmdju.This complaint is for product code z305h, lot shmhks.1.Could you please clarify if the additional device belong to this complaint? 1a.If yes, did a device malfunction occur during the same procedure? 2.If not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to (b)(6) with the ups, dhl or fedex tracker number.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.Related reports: 2210968-2023-03117.

• Brand Name: PDSII VIO 27IN 3-0 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; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16837840
• Report Number: 2210968-2023-03116
• Device Sequence Number: 12477843
• Product Code: NEW
• UDI-Device Identifier: 10705031060395
• UDI-Public: 10705031060395
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2023

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: Z305H
• Device Catalogue Number: Z305H
• Device Lot Number: SHMHKS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 05/04/2023; 05/26/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 05/24/2023; 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• 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