MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 3-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y936H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: please clarify when the needle detached from the suture (during dispensing, during use on patient): during use on patient while closing skin.Did the needle fall into the patient? no.Was the needle retrieve during the same procedure? yes.Was additional tissue incision required to retrieve the needle? no.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2018 and suture was used.During the procedure, while closing the skin, the suture needle popped off.It was not reported how the procedure was completed.There were no patient consequences reported.No product will be returned.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 3-0 UND
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7263844
• MDR Text Key: 99986332
• Report Number: 2210968-2018-70808
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059917
• UDI-Public: 10705031059917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964072
• 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
• Report Date: 01/30/2018

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 Catalogue Number: Y936H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/12/2018
• 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