MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP364H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: it was reported performance dull needle.Two empty opened folder and two used needle/sutures pieces of product code vcp364 were returned for evaluation.During the visual inspection of two needles, the swage and attachment area were noted to be as expected, marks and body fluids could be observed on the body needles.One of two needles was noted with damaged on tip (broken) that appear to be by use of a surgical instrument.Due to this condition, additional evaluation is necessary to determine the failure mode.A second evaluation was performed.A failed suture needle was submitted for fractographic evaluation.The component was identified as product code vcp364h.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.A microscope 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 revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the tip of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020, and suture was used.During the procedure, it was noted that the needle appeared blunt.When examined closely, the tip of the blunt needle does not look jiggered or damaged - blunt to touch.The needle was used on the patient.The tip was not visually inspected prior to use when used.The surgeon complained of blunt feel while pushing through the tissue.An x-ray taken on operating table to exclude tip being left in wound and unable to see.The procedure was successfully completed.There were no adverse patient consequences.Upon evaluation of the returned device, a fracture was observed at the tip of the needle.Additional information has been requested.

• Brand Name: VCL+ VIO 27IN 0 S/A CTX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10567546
• Report Number: 2210968-2020-07186
• Device Sequence Number: 2948631
• Product Code: GAM
• UDI-Device Identifier: 10705031052772
• UDI-Public: 10705031052772
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132580
• 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
• Report Date (Section B): 08/26/2020

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 Model Number: VCP364H
• Device Catalogue Number: VCP364H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/22/2020
• Patient Sequence Number: 1