MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXTRA & EXCEL POLYESTER SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	MB47G
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.
Event or Problem Description
It was reported on user facility medwatch form, # 2300750000-2018-8007.A patient underwent an unknown procedure on an unknown date in (b)(6) 2018 and suture was used.A piece of suture needle broke during graft stitching.Physician was made aware immediately.There were no patient consequences reported.Device is available for return.

• Brand Name: ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7763898
• Report Number: 2210968-2018-75007
• Device Sequence Number: 1757690
• Product Code: GAT
• UDI-Device Identifier: 10705031046283
• UDI-Public: 10705031046283
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2018

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: MB47G
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2018
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 145