MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 2-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y917H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Additional information was requested and the following was obtained: did the needle break into 2 pieces at the swage location? or did the needle pull away / separate from the suture ? did the needle fall into patient? if yes, was it removed? and how? any patient consequences / ae report? patient current status? (b)(6)rep confirmed via phone that the needle came away from the suture; the needle did not break.No broken tip was left in situ.No patient consequence.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.Please clarify the date of the procedure/ event date.

Event Description

It was reported that a patient underwent total knee replacement on unknown date and suture was used.The needle came away from swage after taking a bite of intact tissue.Another suture was used to complete the procedure.No patient consequence reported.

Manufacturer Narrative

The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.A winding former, one paper lid and a detached needle were returned for analysis.However, the suture was not sent.During the visual inspection of the needle, the swage and attachment area of the needle were as expected.The barrel hole of the needle was examined under 20x magnification and no suture remnant was noted.No needle breakage was observed.The suture was not returned to determine the assignable cause.Per the condition of the needle, no defects or broken needle could be observed.Also, it could not be determined what may have caused the reported incident of ¿performance pull off suture needle¿.

• Brand Name: MONOCRYL SUTURE 36"(90CM) 2-0 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: 7104494
• MDR Text Key: 95064272
• Report Number: 2210968-2017-71701
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059825
• UDI-Public: 10705031059825
• Combination Product (y/n): N
• 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: 11/23/2017

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: 02/28/2022
• Device Catalogue Number: Y917H
• Device Lot Number: LCK228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2017
• Initial Date FDA Received: 12/11/2017
• Supplement Dates Manufacturer Received: 12/11/2017
• Supplement Dates FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• 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