MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 2X18IN 4-0 S/A PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Model Number	D10058
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
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.Investigation summary: the product was returned for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one empty opened foil and one winding former with two detached needles and some suture pieces on the degradation process that pertains to the product code d10058 were received for evaluation.The product is a control release; each packet should contain eight strands.Upon visual assessment of the sutures, it was observed that the strands have begun with a degradation process caused by exposure to the environment.This condition contributes to the needle separating from the suture.The foil was visually inspected, and excessive wrinkles and holes in the cavity were observed due to handling.Per the sample condition, the functional test cannot be performed.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture was used.After opening the package before use, it was found that 2 needles had been detached from 2 sutures.Upon visual assessment of the sutures, it was observed that the strands have begun with a degradation process caused by exposure to the environment.This condition contributes to the needle separating from the suture.The foil was visually inspected, and excessive wrinkles and holes in the cavity were observed due to handling.It was a control release needle.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDSII VIO 2X18IN 4-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• 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: 16551184
• Report Number: 2210968-2023-01719
• Device Sequence Number: 4937510
• Product Code: NEW
• UDI-Device Identifier: 10705031134331
• UDI-Public: 10705031134331
• 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,Followup
• Report Date (Section B): 03/16/2023

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: 08/31/2023
• Device Model Number: D10058
• Device Catalogue Number: D10058
• Device Lot Number: MKM096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2018
• 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