MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 4-0 S/A SH-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J771D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: what was the exact issue? please explain:the needle was broken at the swage part.Did the needle got broken? or did the issue was pull off suture needle? please clarify: the needle got broken.Device return follow up.We regularly contact with sales rep about the device returning.No further information will be provided.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used.During the procedure, the needle broke.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4), date sent to the fda: 2/19/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information: d9, h6.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 to determine the fracture mode.The evaluation of (b)(4) revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.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 could not 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 CT BRD VIO 8X18IN 4-0 S/A SH-1 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11111728
• Report Number: 2210968-2021-00008
• Device Sequence Number: 19846137
• Product Code: GAM
• UDI-Device Identifier: 10705031042858
• UDI-Public: 10705031042858
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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 Model Number: J771D
• Device Catalogue Number: J771D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/19/2021
• Patient Sequence Number: 1