MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 4-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y426H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

(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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Did the needle fall into the patient? was the needle retrieved during the same procedure? was additional tissue incision required to retrieve the needle? the device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

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 breaks off of the suture polymer.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: the needle did not fall into the patient.No additional incisions were needed to be made.

Manufacturer Narrative

(b)(4).An unopened sample was sent for analysis.During the visual inspection of unopened 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.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 4-0 UND
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.; avenida de las torres 7125; col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7109370
• MDR Text Key: 94802612
• Report Number: 2210968-2017-71725
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059146
• UDI-Public: 10705031059146
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: Y426H
• Device Lot Number: LJ6449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 01/04/2018; 01/04/2018
• Supplement Dates FDA Received: 01/11/2018; 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2017
• 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