MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A UR-5; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP376H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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 a patient underwent a gynecological procedure on 12/03/2019 and suture was used.During the procedure, the needle broke and the tip was inside the patient.An x -ray revealed the location of the piece and it was removed.The procedure was completed with a like device with no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/28/2020.Additional h3 investigation summary: a suture needle was returned for evaluation.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 (b)(4) revealed the fracture was predominantly 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 manufacturing records couldn't be reviewed as the batch number is unknown.The evidence of this examination indicates that the breakage occurred from mechanical deformation, indents and scratches, due to gripping, bending and overstressing of the needle.  there is no evidence of any material flaw that would cause premature failure.

• Brand Name: VCL+ VIO 27IN 0 S/A UR-5
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9530502
• Report Number: 2210968-2019-91389
• Device Sequence Number: 2217347
• Product Code: GAM
• UDI-Device Identifier: 10705031052895
• UDI-Public: 10705031052895
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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 Model Number: VCP376H
• Device Catalogue Number: VCP376H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 01/28/2020
• Patient Sequence Number: 1