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

Catalog Number	X833H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.Additional information was requested and the following was obtained: procedure name? n/a.When did the reported event occur? intra-op.When was it noticed the needle nip missing? while re-arming- the needle tip was noticed missing when the surgeon reloaded the suture back on the needle driver after securing the pacemaker generator to the muscle (during use on patient).Confirm there was no needle breakage and no needle piece falling into patient during use? patient was examined under fluoroscopy and needle piece was not found.Procedure was completed.
Event or Problem Description
It was reported that a patient underwent an unknown surgical procedure on an unknown date and suture was used.During the procedure it was noticed that the tip of the suture needle was missing.There were no adverse patient consequences.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 01/09/2019.Investigation summary: it was reported performance needle breakage.A package, was submitted for fractographic evaluation.The component was identified as product code x833h.There was no needle provided in the packaging.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.The evaluation revealed there was no needle in the packaging; therefore, no analysis was performed.

• 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: 7725026
• Report Number: 2210968-2018-74656
• Device Sequence Number: 13795372
• Product Code: GAT
• UDI-Device Identifier: 10705031058033
• UDI-Public: 10705031058033
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/29/2018

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: 01/31/2022
• Device Catalogue Number: X833H
• Device Lot Number: LBH555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 01/10/2019
• Patient Sequence Number: 1