MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 5-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y433H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.When did the needle pull off (while in the package / during dispensing / during preparation / during use)? were any attempts made to retrieve the broken piece? if so, was there any additional tissue damage as a result of searching for the needle piece? was the patient brought back to or to attempt retrieving the needle or was it during the initial procedure? were x-rays taken to locate the needle piece(s)? at what location was the needle found? what tissue structure is the needle located? if retained, what is the surgeon's opinion of consequences to the patient? what in the physicians opinion are the factors contributing to the event?.

Event Description

It was reported that a patient underwent a skin closure in (b)(6) 2018 and suture was used.During the procedure, the needle completely separated from the thread.The thread did not break and the needle remained in the patient¿s skin.There were no adverse patient consequences reported.Additional information has been requested.

Manufacturer Narrative

Product complaint #: (b)(4).Additional information was requested and the following was obtained: 1.When did the needle pull off (while in the package / during dispensing / during preparation / during use)? while removing from package with needle driver.2.Were any attempts made to retrieve the broken piece? if so, a.Was there any additional tissue damage as a result of searching for the needle piece? no n/a.B.Was the patient brought back to or to attempt retrieving the needle or was it during the initial procedure? n/a.3.Were x-rays taken to locate the needle piece(s)? n/a.A.At what location was the needle found? n/a.4.What tissue structure is the needle located? n/a.5.If retained, what is the surgeon's opinion of consequences to the patient? n/a.6.What in the physicians opinion are the factors contributing to the event? poor quality craftsmanship.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 5-0 UND
• 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.; avenida de las torres 7125; col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7264219
• MDR Text Key: 99987959
• Report Number: 2210968-2018-70811
• Device Sequence Number: 1
• Product Code: GAN
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

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: 03/31/2022
• Device Catalogue Number: Y433H
• Device Lot Number: LDM214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 02/15/2018
• Supplement Dates FDA Received: 03/07/2018
• Date Device Manufactured: 04/04/2017
• 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