MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 4X30IN 2 S/A V-37; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	MX69G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
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.
Event or Problem Description
It was reported that the patient underwent a hip procedure on (b)(6) 2020 and suture was used.The surgeon was suturing unknown layer of tissue, unknown loop, and the needle broke away from the suture thread.The doctor used like suture to complete the procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 4/10/2020.A manufacturing record evaluation was performed for the finished device batch pjr651, mx69g39 and no non-conformances were identified.

• Brand Name: EB EXC GRN 4X30IN 2 S/A V-37
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9813732
• Report Number: 2210968-2020-01891
• Device Sequence Number: 2769937
• Product Code: GAT
• UDI-Device Identifier: 10705031047150
• UDI-Public: 10705031047150
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: 07/31/2024
• Device Model Number: MX69G
• Device Catalogue Number: MX69G
• Device Lot Number: PJR651
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/10/2020
• Patient Sequence Number: 1