MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y333H
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Component code: device not returned.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.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 being done when the needle came loose from the suture (removal from package / during passage through tissue/ during tying? was the needle removed from the patient during the same procedure? what tissue/location was suturing when pull-off occurred? were there any unexpected outcomes or complications as a result of this suture needle pull-off event? what was done to locate and retrieve the broken needle piece? please provide the procedure name and date.In the event description is sounds like 1 device had an issue.However, according to the impacted product page, it says 1 sales unit was involved.How many products were involved? if more than 1, what was the issue with the other devices? how many devices will be returning? a manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.
Event or Problem Description
It was reported that an animal underwent a surgical procedure on an unknown date and suture was used.The needle broke and the suture was not swedged.Additional information was requested.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 2-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11676496
• Report Number: 2210968-2021-03430
• Device Sequence Number: 3149856
• Product Code: GAN
• UDI-Device Identifier: 10705031058798
• UDI-Public: 10705031058798
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2021

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: 04/30/2025
• Device Model Number: Y333H
• Device Catalogue Number: Y333H
• Device Lot Number: QEMCSD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2021
• Initial Report FDA Received Date: 04/16/2021
• Patient Sequence Number: 1