MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 4-0 S/A J-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J455H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 an unknown surgery on (b)(6) 2019 and suture was used.During the procedure, the needle was broken at the swage part during dermostitch.It was not a control release needle.The broken piece was retrieved, and no pieces remained in the patient.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/17/2020.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 2/19/2020.Additional information: d10, h4, h6.A manufacturing record evaluation was performed for the finished device pck183 batch number, and no non-conformances were identified.Additional h3 investigation summary: a suture needle was returned for evaluation.A fracture was observed at the suture attachment 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 composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage, a cup-and-cone shaped fracture 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 at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.

• Brand Name: VCL CT BRD UD 27IN 4-0 S/A J-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9488883
• Report Number: 2210968-2019-91060
• Device Sequence Number: 3541721
• Product Code: GAM
• UDI-Device Identifier: 10705031040038
• UDI-Public: 10705031040038
• 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,Followup
• Report Date (Section B): 11/28/2019

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: 02/29/2024
• Device Model Number: J455H
• Device Catalogue Number: J455H
• Device Lot Number: PCK183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 12/22/2019; 01/27/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/17/2020; 02/19/2020
• Patient Sequence Number: 1