MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 1 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y359H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.Can you confirm if detachment issue with both needles presented during use on single patient / same procedure? also confirm when was the detachment issue noticed? a- pre-op / before use on patient while in package or while dispensing? b- intra-op / during use on patient or while suturing? was procedure completed successfully? and how? are samples available to be returned from both codes/lots of reported sutures?.

Event Description

It was reported that patient underwent unknown procedure on (b)(6) 2018 and suture was used.The suture pulled out from the swage of the needle.There were no adverse patient consequences reported.Additional information was requested.

Manufacturer Narrative

(b)(4).An empty opened foil, paper lid,a winding former with an undispensed suture, empty winding former, and a only detached needle with no suture of product were returned for analysis.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.During the visual inspection of sample, the swage and the swage attachment area were as expected.The barrel hole was examined under magnification for suture remnant and none was noted.The suture was examined and the insertion end was measured and did not meet the requirement.Per the condition of the undispensed sample, the assignable cause of the performance - pull off suture needle is a short insertion.The actual, used sample was examined and the swage and attachment area were as expected.The barrel hole was examined under magnification for suture remnant and none was noted.The needle had a normal swaged.Slightly marks on the body of the needle that appears to be by the use of a surgical instrument could be observed.The suture was not returned to determine the assignable cause.As only the needle and not the suture was returned for the actual/used sample, no conclusion cold be reached as to what may have caused the reported incident.

• Brand Name: MONOCRYL SUTURE 36"(90CM) 1 VIO
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7535222
• MDR Text Key: 108996458
• Report Number: 2210968-2018-72977
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K960653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: Y359H
• Device Lot Number: LHM619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/29/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 06/08/2018
• Supplement Dates FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2017
• 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