MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 2-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y417H
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).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.Please clarify the event; did the suture break or the needle pulled off from the suture thread? how many device involved with this complaint? are multiple procedures being reported? if yes, how many? for each procedure please provide the following information- event date.Procedure name.Product code & lot if different.Quantity involved.Event description stating when each device malfunctioned.How was case completed.Any adverse patient consequences and what medical/surgical intervention was provided? is the sample still available of evaluation? if yes, please provide facility contact person¿s name, mailing address, telephone number and email address, to whom a shipper kit be sent to return the sample.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture had consistently been malfunctioning.It is a running suture, but the needle has been breaking off from the suture while in use.It is unknown if another like device was used to complete the procedure.There were no adverse consequences for the patient.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda; 06/10/2019.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: MCRYL UD 27IN 2-0 S/A SH
• 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: 8623440
• Report Number: 2210968-2019-81507
• Device Sequence Number: 2257948
• Product Code: GAN
• UDI-Device Identifier: 10705031059139
• UDI-Public: 10705031059139
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

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 Expiration Date: 06/30/2023
• Device Catalogue Number: Y417H
• Device Lot Number: MHM278
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 06/10/2019
• Patient Sequence Number: 1