MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 3-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP316H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/28/2024.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 lot number.-was there any change in the patient¿s post-operative care due to the prolonged procedure? - please clarify, did the needle detached from the suture or did the suture broke during use on the patient? it was reported that "was procedure successfully completed? no".Please provide additional details about the reported event.The following information was reported: was surgery delayed due to the reported event? yes, if yes, number of minutes: 2, action taken when event occurred? suture was removed & replaced with new suture that was used successfully.Was procedure successfully completed? no, were fragments generated? no, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences? no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study? unknown, (b)(4).Device property of? hospital, device in possession of? product specialist.H3 investigational summary: the product was returned to ethicon.One needle suture piece was received for analysis.During visual inspection of the returned sample, marks that appear to be caused by a surgical instrument were observed on the body needle.The suture was examined, and the end of the suture was noted to be cut probably caused by a surgical instrument.In addition, body fluids and damage (crushed) were found on the strand.The other section of the suture was not returned for analysis.This product code pdp316 contains an absorbable suture.Since the sample was received open, the functional test could not be performed due to undetermined exposure time to the environment.As part of the 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.
Event or Problem Description
It was reported that a patient underwent a sleeve gastrectomy procedure on (b)(6) 2024 and suture was used.A suture was being used to effect a repair to a small defect on a patient¿s stomach during a lap sleeve gastrectomy.When throwing the first pass through stomach tissue the suture came apart as the surgeon was pulling the suture through the tissue by grasping the needle to do so.It broke off approximately 3-5mm from the end of the needle.There were no patient consequences reported.Additional information was requested.

• Brand Name: PDS+ VIO 27IN 3-0 S/A SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20545842
• Report Number: 2210968-2024-11148
• Device Sequence Number: 7873246
• Product Code: NEW
• UDI-Device Identifier: 10705031048027
• UDI-Public: 10705031048027
• Combination Product (Y/N): Y
• Initial Reporter Country: NZ
• PMA/510(K) Number: K061037
• 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): 10/28/2024

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: PDP316H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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