MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y345H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: was the needle removed from the animal during the same procedure? i¿m not sure what you mean by the needle being removed from the patient during the same procedure.The needle came off the suture while the doctor was attempting to close the linea during a canine ovariohysterectomy.Was there any animal consequence or injury? the only consequence was the additional anesthesia time while the doctor removed the suture and then re-sutured.Anesthesia and recovery were both uneventful for the patient.Procedure name and date? the procedure was a canine ovariohysterectomy, but i do not have a date.How was case completed? the empty suture packet was left for me.The suture itself was actually thrown away.A manufacturing record evaluation was performed for the finished device lot ppmeze, and no non-conformance's were identified.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.
Event or Problem Description
It was reported that a dog underwent a ovariohysterectomy procedure on (b)(6) 2020; and a suture was used.During the procedure, the needle fell off the suture.

• Brand Name: MONOCRYL SUTURE 36"(90CM) 2-0 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: 10315191
• Report Number: 2210968-2020-05513
• Device Sequence Number: 2613135
• Product Code: GAN
• UDI-Device Identifier: 10705031058897
• UDI-Public: 10705031058897
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2020

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: 11/30/2024
• Device Model Number: Y345H
• Device Catalogue Number: Y345H
• Device Lot Number: PPMEZE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 07/23/2020
• Patient Sequence Number: 1