MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 30"(75CM) 3-0 GRN; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	X872H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pc-(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 an unknown procedure on an unknown date and suture was used.During the procedure, the suture broke while tying the knot.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 12/10/2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/15/2019.Device evaluation summary: an empty winding former, a paper lid and a dispensed suture code x872, lot lhh501 were returned for analysis.During the visual inspection of the suture, body fluids were noted in some parts and the end was busted.A functional test was performed using a instron and the tensile force were above the minimum requirements.The needle was not returned for analysis.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 manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to the sample condition, the assignable cause of performance breakage suture, was suggests an improper handling of the sample.

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 3-0 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: 8084757
• Report Number: 2210968-2018-77234
• Device Sequence Number: 2364505
• Product Code: GAT
• UDI-Device Identifier: 10705031058187
• UDI-Public: 10705031058187
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 10/24/2018

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: 06/30/2022
• Device Catalogue Number: X872H
• Device Lot Number: LHH501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 11/20/2018; 01/10/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/10/2018; 01/15/2019
• Patient Sequence Number: 1