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

Catalog Number	X424H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts are being 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 an unknown procedure on (b)(6) 2018, and a suture was used.During surgery, the suture broke during sewing in the pelvic floor reconstruction.A replacement device was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Corrected information: to date the device has not been returned to manufacturer for evaluation.
Additional Manufacturer Narrative
(b)(4).Investigation summary: it was reported performance breakage suture.A labeled winding former and a suture piece were returned for analysis.During the visual inspection of suture piece, presented body fluids, elongation and the end of the suture was busted (damaged).The other end was cut that appear to be by the use of a surgical instrument.In addition, a functional test was performed on the sample and the tensile force met the requirements.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition of the sample received, the assignable cause of the breakage suture suggest 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: 8222551
• Report Number: 2210968-2019-78235
• Device Sequence Number: 264462
• Product Code: GAT
• UDI-Device Identifier: 10705031057272
• UDI-Public: 10705031057272
• 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,Followup
• Report Date (Section B): 12/10/2018

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: 07/31/2022
• Device Catalogue Number: X424H
• Device Lot Number: LJH157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 01/07/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 01/07/2019; 02/04/2019
• Patient Sequence Number: 1