MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 6-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	1956G
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 that a patient underwent an excision of a lesion on the neck on (b)(6) 2018 and suture was used.During the procedure, the suture popped off the needle at the swage.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > an unopened sample was returned for analysis.During the visual inspection of sample, no defects were found on the package.The sample was opened and the swage and attachment area of the needle were as expected.The suture was dispensed without problems and examined along of the strand and no defects were observed.The sample was tested by needle pull and meet the finished goods requirements.Per the conditions of the sample received, no attachment defects were found and the tested sample met the finished goods requirements.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to fda: (b)(4) 2018.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: ETHILON SUTURE 18"(45CM) 6-0 BLK
• 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: 7296150
• Report Number: 2210968-2018-71044
• Device Sequence Number: 16462809
• Product Code: GAR
• UDI-Device Identifier: 10705031003095
• UDI-Public: 10705031003095
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2018

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: 1956G
• Device Lot Number: LHH040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 02/23/2018; 02/23/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 03/12/2018; 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1