MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 8X18IN 3-0 S/A SH CR; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z774D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/16/2023 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.The following additional information was requested: *device follow up h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned product determined that it was received one winding former with eight suture pieces partially dispensed that pertains to product code z774d.The product code is control release and requires eight strands per packet.During visual inspection of the returned sample, the sutures were examined, and the extremes of all sutures were noted to be cut probably caused by a surgical instrument.In addition, the needles weren¿t received.As per conditions of the returned sample, no functional test could be performed.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.Related reports: 2210968-2023-08901, 2210968-2023-08902, & 2210968-2023-08903.
Event or Problem Description
It was reported,that a patient underwent a breast reconstruction procedure on (b)(6)2023 and suture was used.During a breast reconstruction procedure that four sutures broke about two inches from the needle.New sutures were opened from the same lot to complete the procedure.There were no adverse consequences for the patient.Additional information was requested.

• Brand Name: PDSII VIO 8X18IN 3-0 S/A SH CR
• 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: 18148866
• Report Number: 2210968-2023-08900
• Device Sequence Number: 20735380
• Product Code: NEW
• UDI-Device Identifier: 10705031061736
• UDI-Public: 10705031061736
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2023

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 Expiration Date: 03/31/2025
• Device Catalogue Number: Z774D
• Device Lot Number: QDMALZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2020
• 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