MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 4-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y315H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch qhmcsz, y315h and no non-conformances were identified.Additional information was requested, and the following was obtained: could you please confirm how many sutures presented the issue of breakage during the animal surgery procedure? did this event happened in more than one procedure? if yes, how many procedures and how many devices in each procedure? could you please confirm if the device is available for return? i was doing a surgery and tying a knot and when i put the appropriate amount of pressure on the suture material it broke.So then i started to just test the suture material i had left and with light pull it broke.Not at all what i expected.I opened another pack it was also defective and broke too easily.So i stopped opening packs went to a different suture entirely like pds and finish the surgery.I have not used the product since.I then tried another lot of 4-0 monocryl and it handled properly.Events were submitted via 2210968-2021-01554.
Event or Problem Description
It was reported by vet that the animal underwent an animal procedure on unknown date and the suture was used.During use or tying a knot, the suture was breaking too easily when the appropriate amount of pressure on the suture material was placed.Another type of suture was used to complete the procedure.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 4-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11345032
• Report Number: 2210968-2021-01559
• Device Sequence Number: 11632592
• Product Code: GAN
• UDI-Device Identifier: 10705031058729
• UDI-Public: 10705031058729
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2021

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: 06/30/2025
• Device Model Number: Y315H
• Device Catalogue Number: Y315H
• Device Lot Number: QHMCSZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/18/2021
• Patient Sequence Number: 1