MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 27"(70CM) 0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J329H
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).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 the patient underwent an unknown procedure on an unknown date and suture was used.The needle broke in half when closing the incision.The broken piece was found, and the procedure was not delayed.Another like device was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Investigation summary: it was reported performance needle breakage.A failed suture needle was submitted for fractographic 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 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 and a cup-and-cone shaped fracture observed coincidental to the fracture provide 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: VICRYL SUTURE 27"(70CM) 0 VIO
• 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: 8506082
• Report Number: 2210968-2019-80286
• Device Sequence Number: 1628669
• Product Code: GAM
• UDI-Device Identifier: 10705031038875
• UDI-Public: 10705031038875
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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 Catalogue Number: J329H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/13/2019
• Patient Sequence Number: 1