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

Catalog Number	Y345H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.When did the issue occur; in the package/ during dispensing (before use on patient/during actual suturing (use on patient)? please confirm the number of devices that failed during this single procedure.Name of the procedure? what was the date of the initial procedure? date the event occurred? lot number.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on unknown date and suture was used.The thread came of the needle.There were no adverse patient consequences reported.Additional information has been requested.

• 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: 9507041
• Report Number: 2210968-2019-91207
• Device Sequence Number: 11115266
• Product Code: GAN
• UDI-Device Identifier: 10705031058897
• UDI-Public: 10705031058897
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

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 Catalogue Number: Y345H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/20/2019
• Patient Sequence Number: 1