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

Model Number	Y464G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During use on the patient it was noted that the needle broke.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: what was the initial procedure? what is the lot number? did the needle fall into the patient? if yes were x-rays taken to locate the needle piece(s)? was the needle piece(s) retrieved during the same procedure? does a piece of the needle remain in the patient¿s tissue? what tissue structure is it located? what measures were taken to retrieve the broken piece? was there any additional tissue damage as a result of searching for the needle piece?what is current condition of the patient?.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent to the fda: 2/16/2022.H6 component code: g07002 no device problem found.H3: investigational narrative: an analysis of the product could not be performed since the needle physical was not received for evaluation, only an empty labeled wining former and a suture piece were received.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.As part of ethicon's quality process, each batch is randomly visually inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product is received at a later date, the investigation will be updated as applicable.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: MCRYL VIO 18IN 4-0 S/A P-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.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13256187
• Report Number: 2210968-2022-00395
• Device Sequence Number: 4229048
• Product Code: GAN
• UDI-Device Identifier: 10705031059269
• UDI-Public: 10705031059269
• Combination Product (Y/N): N
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: Y464G
• Device Catalogue Number: Y464G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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