MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 8X18IN 5-0 S/A RB-1 CR MP; SUTURES - ABSORBABLE

Catalog Number	Z711D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a sales rep that, during an unknown surgery, it was very hard to detach the needle from the suture.It was a control release needle.Further details are not provided from the hp.No sample will be returned.There were no adverse consequences to the patient.Affiliate reference number is (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/19/2023.H6 component code: g07002 - device not returned.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.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: please advise if the following additional products also had an issue during the same patient procedure or are these products being returned for analysis and/or replacement? tcmres : smmaue : skmdkz : samqde: the following information was received: qty to be returned : 10 => 22.Lot number : thmesu.Tcmres : 6 packages.Smmaue : 2 packages.Skmdkz : 1 packages.Samqde: 1 packages.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 Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 2/6/2024.H6 component code: g07002.No device problem found.Additional information was requested, the following was obtained: the new information indicates (b)(4) products will be returned and the lot number is thmesu.Please advise if the following additional products also had an issue during the same patient procedure or are these products being returned for analysis and/or replacement? these are reference products.Tcmres: (b)(4) packages: refernce products.Smmaue: (b)(4) packages: refence products.Skmdkz: (b)(4) package: refence products.Samqde: (b)(4) package: refence products.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned sample determined that one winding former with three undispensed strands and five sutures dispensed that pertains to product code z711d were returned for analysis.The product code is control release, and each packet contains eight strands.In order to evaluate the conditions of the returned sample, the five needles were not received for evaluation.The five dispensed sutures were examined, and a mark of correct insertion was noted in the extremes of the suture.The sutures were dispensed without problems and examined along the strand no anomalies were observed during the evaluation.The functional test was performed, and the pull force results met the requirement.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.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned sample determined that it was received, seven unopened samples that pertain to the product code z711d.Upon initial inspection, of the samples, no external damages were observed on the packets.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during the evaluation.A functional test was performed using instron equipment and the pull force results met the requirement.The event described could not be confirmed as the device performed without any defect noted.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.

• Brand Name: PDSII VIO 8X18IN 5-0 S/A RB-1 CR MP
• Common Device Name: SUTURES - 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: 18354965
• Report Number: 2210968-2023-09858
• Device Sequence Number: 6594202
• Product Code: NEW
• UDI-Device Identifier: 10705031061590
• UDI-Public: 10705031061590
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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: Z711D
• Device Lot Number: THMESU
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• 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