MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J426H
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
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.Additional information was requested and the following was obtained: what is the lot number? remcrx could you please confirm if it was possible that the needle got broken? please confirm unsure if the needle was broken when it came out of the package or if broken during the procedure.Surgeon didn¿t feel it was broken during the procedure.Could you please confirm if it was a surface related needle? please confirm needle/suture was being used at the subcuticular layer.Please confirm what was the exact issue? surgeon took a couple of passes and commented that the needle was challenging to push through tissue.She commented that the needle didn¿t seem to have a tip to it.Both the surgeon and technician could not find anything that looked to be a needle tip on the sterile field.
Event or Problem Description
It was reported that a patient underwent an unknown gyn procedure on (b)(6) 2021 and suture was used.During the procedure, when closing the subcuticular layer, it was noticed that the needle did not have a tip.It was reported to be missing before removed from package.Another like device was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/12/2021.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.H3 evaluation: the product was returned for evaluation.Visual analysis of the returned sample determined that on broken needle at the tip product code j426h was received.Marks on the tip due to use of the surgical instrument were observed.Additional evaluation is necessary to determine the assignable cause of the breakage needle.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/22/2021.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.H3 investigation summary: a suture needle was submitted for fractographic evaluation on september 29, 2021.The component was identified as product code j426h.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.A scanning electron microscope 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 revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the tip of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end.

• Brand Name: VCL CT BRD UD 27IN 4-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12513205
• Report Number: 2210968-2021-08744
• Device Sequence Number: 3908323
• Product Code: GAM
• UDI-Device Identifier: 10705031039773
• UDI-Public: 10705031039773
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2021

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: 04/30/2026
• Device Model Number: J426H
• Device Catalogue Number: J426H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/15/2021; 10/18/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/12/2021; 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1