MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 4-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y315H
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).Date sent to the fda: 04/13/2020.A manufacturing record evaluation was performed for the finished device pg6799 batch number, and no non-conformance's were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to clarify 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 a quantity of sutures involved in this event ¿the needle popped off of several sutures¿ during this single procedure on one patient? the single complaint was reported with multiple events.There are no additional details regarding the additional events.Events were submitted via 2210968-2020-02981 and 2210968-2020-02982.
Event or Problem Description
It was reported that the patient underwent an unknown oral surgery in 2020 and the suture was used.During the procedure, the needle popped off of suture.A new device was used to complete the procedure successfully with no patient consequences.It was also reported that the needle removed from the patient but no radiographs were taken as it was oral surgery and the needle was located visually.Additional information has been requested.
Additional Manufacturer Narrative
Date sent to the fda: 04/29/2020.Corrected information: d3, g1, g2.Additional information was requested, and the following was obtained: please clarify a quantity of sutures involved in this event ¿the needle popped off of several sutures¿ during this single procedure for this one patient?- the instance of the needle popping off several pieces of suture did not happen over the course of one surgery but over the course of a few procedures with different patients.In each case, another pack of suture from the same lot and box was used to complete the procedure.All the needles were retrieved and accounted for prior to finishing the surgical procedures.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 4-0 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: 9953727
• Report Number: 2210968-2020-02982
• Device Sequence Number: 2765156
• Product Code: GAN
• UDI-Device Identifier: 10705031058729
• UDI-Public: 10705031058729
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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: 05/31/2024
• Device Model Number: Y315H
• Device Catalogue Number: Y315H
• Device Lot Number: PG6799
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 04/29/2020
• Patient Sequence Number: 1