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

Catalog Number	VCP740D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.The needle was broken at the body part when pulling after passing the needle through the tissue.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: we get this info from the actual product lot number: unknown = mk2925 h3 device evaluation summary: the actual device component was identified as product code vcp740d was received for evaluaton.A fracture was observed in the body of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation of pc-000476135 revealed the fracture was predominantly intergranular, which is evidence of a brittle failure.This was a non-ductile fracture.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.The needle exhibited amounts of intergranular failure.A manufacturing record evaluation was performed for the finished device number mk2925, and no non-conformances were identified.

• Brand Name: VCL+ VIO 8X18IN 0 S/A CT-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8741355
• Report Number: 2210968-2019-83403
• Device Sequence Number: 2534842
• Product Code: GAM
• UDI-Device Identifier: 10705031055193
• UDI-Public: 10705031055193
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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 Catalogue Number: VCP740D
• Device Lot Number: MK2925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 07/07/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/01/2019
• Patient Sequence Number: 1