MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL GRN 110CM M3.5; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	EC11
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device 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 a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2020 and suture was used.The thread pulled off of the needle.Another device was used to complete the procedure.There were no adverse patient consequences reported.

• Brand Name: ETHIBOND EXCEL GRN 110CM M3.5
• 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: 9765506
• Report Number: 2210968-2020-01586
• Device Sequence Number: 19495674
• Product Code: GAT
• UDI-Device Identifier: 10705031148147
• UDI-Public: 10705031148147
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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: 06/30/2024
• Device Model Number: EC11
• Device Catalogue Number: EC11
• Device Lot Number: PHK066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/27/2020
• Patient Sequence Number: 1