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

Catalog Number	X412H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2018
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 that a patient underwent a pelvic floor reconstruction on (b)(6) 2018 and suture was used.During the procedure, the suture broke.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.
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.A labeled winding former with a re-parked needle/suture piece was returned for analysis.During the visual inspection of sample, the swage and attachment area were as expected.Marks were observed on the body needle appears to be by use of a surgical instrument.The suture piece present body fluids along of strand, also the end of suture present elongation and damaged (cut) appears to be by use of a surgical instrument were observed.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.The sample was tested by knot tensile strength and the result was above the minimum individual strength requirement.Due to the sample condition, the assignable cause of performance breakage suture, suggests an improper handling of the sample.

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 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: 7264576
• Report Number: 2210968-2018-70818
• Device Sequence Number: 1316699
• Product Code: GAT
• UDI-Device Identifier: 10705031057234
• UDI-Public: 10705031057234
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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 Expiration Date: 07/31/2020
• Device Catalogue Number: X412H
• Device Lot Number: JJB275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1