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

Model Number	J714D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 12/14/2020.(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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested, but unavailable: what was used to complete the procedure? no further information is available.Did the surgery was completed successfully? no further information is available.What is the event day and procedure date? no further information is available.
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 when trying to detach the needle from the suture, the needle tip was broken, and it fell on the surgical field.The broken needle and needle tip have been retrieved.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 02/01/2021 additional information: d9, h3, h6 h3 analysis summary: a failed suture needle was submitted for fractographic evaluation.A fracture was observed in the body of the needle.The needle was received in two pieces.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.He 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.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.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.

• Brand Name: VCL CT BRD UD 8X18IN 4-0 S/A RB-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: 11003577
• Report Number: 2210968-2020-09892
• Device Sequence Number: 11653221
• Product Code: GAM
• UDI-Device Identifier: 10705031042483
• UDI-Public: 10705031042483
• 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): 11/24/2020

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: 06/30/2025
• Device Model Number: J714D
• Device Catalogue Number: J714D
• Device Lot Number: QHMKKL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 02/01/2021
• Patient Sequence Number: 1