MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 3-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 1669H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle separated from the suture at the swage.No additional information was available.It was unknown how the procedure was completed.No adverse patient consequences were reported.

Manufacturer Narrative

Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Investigation summary: unopened samples were received for evaluation.The issued sample was not received for evaluation.During the visual inspection of samples, no defects were found on the package.The samples were opened and the swage and attachment area needles were as expected.The sutures were dispensed without problems and examined along of the strand and no defects were observed.A functional test was performed using a instron and the pull force were above the minimum requirements.Per the conditions of the samples received, no attachment defects were found and the tested sample met the finished goods requirements.

Manufacturer Narrative

Product complaint # pc-(b)(4) date sent to the fda: (b)(4) 2018.Additional event description: needle driver stabilized needle, pulled tail of the suture, needle detached from suture.Date of event: (b)(4) 2018.Attachment:(b)(4).

• Brand Name: ETHILON SUTURE 18"(45CM) 3-0 BLK
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7549137
• MDR Text Key: 109417779
• Report Number: 2210968-2018-73106
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10705031001879
• UDI-Public: 10705031001879
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 1669H
• Device Lot Number: LEP488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR