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

Catalog Number	J376H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.Additional information was requested and the following was obtained: after the needle fragment fell into the body, when the wound which had been partially sutured was reopened, the needle fragment was visually found.There is no problem with the patient's condition.The surgeon commented, ¿it is unclear why it broke.¿.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2019 and suture was used.The needle was broken at the body part during fascia closure by interrupted suturing.The broken needle was dropped in the abdominal cavity.The wound was re-opened, and the broken needle was retrieved, then the wound was re-closed.The operation time was extended within 30 minutes.No additional treatment is planned.
Additional Manufacturer Narrative
(b)(4).Additional 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 revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage and macroscopic plastic deformation 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 were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.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 CT BRD 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 0151
• MDR Report Key: 8805787
• Report Number: 2210968-2019-84470
• Device Sequence Number: 13534711
• Product Code: GAM
• UDI-Device Identifier: 10705031039438
• UDI-Public: 10705031039438
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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): 06/24/2019

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: 11/30/2023
• Device Catalogue Number: J376H
• Device Lot Number: MPZ261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/22/2019
• Patient Sequence Number: 1