MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 18"(45CM) 5-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y822G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.Were the needles that broke from the same product code / lot / batch? did the needles break and fall into patient? if yes, were they retrieved? and how? was the procedure completed successfully? and how? any patient consequences / ae outcome as a result of the event reported? any samples available to be returned for evaluation? if yes, please provide the contact name and mailing address for the return shipper kit to be sent.
Event or Problem Description
It was reported that a patient underwent an unknown procedure and suture was used.During the procedure, the needle broke while suturing the patient.It is unknown how the procedure was completed.There were no adverse consequences reported for the patient.

• Brand Name: MONOCRYL SUTURE 18"(45CM) 5-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7515058
• Report Number: 2210968-2018-72795
• Device Sequence Number: 11186535
• Product Code: GAN
• UDI-Device Identifier: 10705031059634
• UDI-Public: 10705031059634
• Combination Product (Y/N): N
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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: 09/30/2022
• Device Catalogue Number: Y822G
• Device Lot Number: LL6677
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1