MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 3-0 S/A SH-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J772D
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from the analysis of the returned product that suture degradation was observed, the suture pieces could not be dispensed since they had begun with the process of degradation and the time of exposure of sutures to the environment could not be determined.It was reported that a patient underwent a robot-assisted total gastrectomy procedure on (b)(6) 2022 and a suture was used.When the aluminum package was opened, it was found that all sutures had come off.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested, but unavailable: it was reported that all sutures had come off, could you please provide more details?no further information is available.How many sutures are involved in this event? no further information is available.Device return status: we regularly contact with sales rep about the device returning.No further information will be provided.Investigational summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that it was received a winding former with eight detached needles and suture pieces that pertain to product code j772d.This product is control release and required eight strands per packet.Upon visual assessment of the returned sample, no assembly error were noted.However, it was observed that all needles were detached from the sutures.The needles were examined, and the swage and attachment area were noted to be as expected.The barrel hole of the needles was examined under 20x magnification and remnant suture could be observed.The suture pieces could not be dispensed since they had begun with the process of degradation and the time of exposure of sutures to the environment could not be determined.The foil was visually inspected, and excessive wrinkles and holes in the cavity were observed due to handling.Due to returned condition of the sample, no functional test could be performed.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.

• Brand Name: VCL CT BRD VIO 8X18IN 3-0 S/A SH-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16230777
• Report Number: 2210968-2023-00375
• Device Sequence Number: 12360029
• Product Code: GAM
• UDI-Device Identifier: 10705031042872
• UDI-Public: 10705031042872
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2023

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: 08/31/2023
• Device Model Number: J772D
• Device Catalogue Number: J772D
• Device Lot Number: MKK935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2018
• 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