MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y317H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Clarify when the suture separated from the needle (while in the package, while dispensing, during use)? what is the lot number? attempts are being 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 patient underwent an unknown procedure on (b)(6) 2018 and a suture was used.During surgery, the suture was found to be defective as the thread detached from the needle.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 2-0 VIO
• 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: 8162000
• Report Number: 2210968-2018-77743
• Device Sequence Number: 2370518
• Product Code: GAN
• UDI-Device Identifier: 10705031058767
• UDI-Public: 10705031058767
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 11/20/2018

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 Catalogue Number: Y317H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/13/2018
• Patient Sequence Number: 1