MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 30"(75CM) 2-0 GRN; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	X833H
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.Specific number of devices with needle pulled off issue during this procedure was any additional tissue dissection required or damage occur during searching/retrieving needles from the patient? how was case completed? 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 that the patient underwent an incisional hernia procedure on (b)(6) 2018 and suture was used.During the procedure, the needle popped off.The surgeon had to dig in the patient's tissue to retrieve some of them.It was unknown how the procedure was completed.There were no patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
Additional Manufacturer Narrative
Pc-(b)(4).Representative samples received.No defects were found on the package.The sample was opened and the swage and attachment area of the needles were as expected.The suture was dispensed without problems and examined along of the strand and no defects were observed.

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 2-0 GRN
• 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: 7287855
• Report Number: 2210968-2018-70972
• Device Sequence Number: 13822024
• Product Code: GAT
• UDI-Device Identifier: 10705031058033
• UDI-Public: 10705031058033
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2018

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: X833H
• Device Lot Number: LJJ358
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2018
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 02/26/2018; 03/19/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/09/2018; 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1