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

Catalog Number	PX83H
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: was additional tissue incision required to retrieve the needle? no.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 the patient underwent an unknown procedure on (b)(6) 2017 and suture was used.During the procedure, the needle pulled off the suture.The needle pulled off in tetralogy of fallot.It was retrieved from patient.Another like suture was used to complete the procedure.There were no adverse patient consequences.
Additional Manufacturer Narrative
Pc-(b)(4).A dispensed needle-suture combination and one empty opened folder was received for analysis.The product code is double armed.During the visual inspection of the needle-suture, the swage and attachment area were as expected.The suture was examined and the insertion end was measured and did not meet the requirement.In addition, another needle was not returned for evaluation.Per the sample condition, the assignable cause of the performance - pull off suture needle is a short insertion.This defect is caused because the insertion of the suture in the needle was insufficient from keep the needle/suture union during transportation or use.
Additional Manufacturer Narrative
Pc-(b)(4).

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 2-0 WHT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7244566
• Report Number: 2210968-2018-70697
• Device Sequence Number: 13689273
• Product Code: GAT
• UDI-Device Identifier: 10705031049260
• UDI-Public: 10705031049260
• 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): 01/17/2018

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 Catalogue Number: PX83H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 02/07/2018; 02/26/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 02/21/2018; 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1