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

Catalog Number	Z310H
Medical Device Problem Codes	Material Separation (1562); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2024 and suture was used.During the procedure, it was reported by a sales rep that, when pulled out the suture, the catch was hard and the connection part between the suture and the needle sometimes came off.It was not a control release needle.There were no adverse consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).H6 component code: g07002: no device problem found.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-conformance's 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 provide the name of procedure.When did the needle detach or pull off from the suture (in the package, during removal from the package, during handling prior to using on the patient, or during use on the patient)? it was reported that "the catch was hard".Please provide more details about this issue.It was reported that "the suture and the needle sometimes came off".Please clarify how many devices were affected by the reported event (the suture and the needle sometimes came off).Please confirm the quantity being returned.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.H3 investigation summary: the product was returned to ethicon for evaluation.Eighteen representative unopened samples were received for analysis.Product code z310h.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external packets.In the inspection of the returned samples, these ones were tested to verify the dispensability of the sutures, and it was not possible in fifteen samples due to the suture being found hard to release from the tray by applying excessive force.In the remaining three samples, the sutures were dispensed without problems from the winding former.The functional test was performed on the three dispensed samples using an instron equipment and the pull force result was above the minimum requirements.Based on the information currently available, the indispensable suture was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.

• Brand Name: PDSII VIO 27IN 4-0 S/A SH-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: 20012128
• Report Number: 2210968-2024-08688
• Device Sequence Number: 17956386
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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: Z310H
• Device Lot Number: TEMHUM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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