MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 30"(75CM) 2 G/W/LG; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	D8449
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported a patient underwent an anterior cruciate ligament reconstruction on (b)(6) 2018 where suture was use.During the procedure, the suture was broken after suturing the graft and the tendon.The event occurred during bending and stretching the knee with the wound was opened to confirm the motion and the tension.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Evaluation: an opened box with unopened samples of product was returned for analysis.The product code is double armed.The product code required double armed strands per packet.During the visual inspection of the samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strands with no defects or suture breakage observed.A functional test was performed and tensile strength was above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples received, no performance breakage suture was found.

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 2 G/W/LG
• 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: 7846681
• Report Number: 2210968-2018-75622
• Device Sequence Number: 16629396
• Product Code: GAT
• UDI-Device Identifier: 10705031030206
• UDI-Public: 10705031030206
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/09/2018

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: D8449
• Device Lot Number: LJM605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/03/2018
• Patient Sequence Number: 1