MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 4-0 S/A PC-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y845G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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: it was noticed that "a tiny portion of the needle is seen still attached to the suture remnant."was the needle piece(s) retrieved during the same procedure? yes.Was there any additional tissue damage as a result of searching for the needle piece? no.What is current condition of the patient? ok.What was the size of the needle used? as per catalog: 16mm.Was more than half the needle retained in the patient? no part of the needle was retained in the patient.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a removal of a breast lesion on (b)(6) 2021 and suture was used.During the procedure, the needle broke at the swage.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) date sent to the fda: 02/09/2022 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, 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: h6, d9, h3 h3 evaluation: a failed suture needle, labeled as (b)(4) was submitted to fractographic evaluation.The component was identified as product code y845g.It was requested that assess the fracture mode of the failure.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 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 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 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.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 to the point.The needle breakage was confirmed.

• Brand Name: MCRYL UD 18IN 4-0 S/A PC-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13087720
• Report Number: 2210968-2021-12964
• Device Sequence Number: 20261587
• Product Code: GAN
• UDI-Device Identifier: 10705031059740
• UDI-Public: 10705031059740
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

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: 05/31/2026
• Device Model Number: Y845G
• Device Catalogue Number: Y845G
• Device Lot Number: RGMDBZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown