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

Model Number	J376H
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
Product complaint: (b)(4).Date sent to the fda: 04/01/2020.A manufacturing record evaluation was performed for the finished device batch number mjk590, and no non-conformance's were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an unknown procedure in 2020 and the suture was used.During the procedure, the needle broke into two pieces while passing through tissue, unknown layer of tissue, unknown loop.The broken pieces were retrieved from the patient, found visually, no x-ray was needed.A second like needle was used to complete the procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 04/28/2020.Corrected information: d3, g1, g2.Additional information: d10, h6.Additional h3 investigation summary: a failed suture needle was for fractographic evaluation.The components were identified as product code j376h.A fracture was observed in the body of the sample.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.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 needles.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation revealed the fractures were composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage, a cup-and-cone shaped fractures 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 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
• MDR Report Key: 9914328
• Report Number: 2210968-2020-02524
• Device Sequence Number: 3296312
• Product Code: GAM
• UDI-Device Identifier: 10705031039438
• UDI-Public: 10705031039438
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

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 Expiration Date: 07/31/2023
• Device Model Number: J376H
• Device Catalogue Number: J376H
• Device Lot Number: MJK590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/28/2020
• Patient Sequence Number: 1