MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 4-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 662G

Device Problem Detachment Of Device Component (1104)

Patient Problem Not Applicable (3189)

Event Date 01/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation summary: the actual device involved in this event was returned for evaluation.The evaluation found that the swage and attachment area were as expected.The barrel hole was examined and suture remnant was noted.In addition, marks on the edge and body of the needle that appears to be by use of a surgical instrument could be observed, being the cause of detached needle.In order to avoid this kind of damage, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.According the sample condition, the assignable cause of performance-pull off suture needle, suggest an improper handling of the sample.Representative samples were returned for evaluation.They were visually and functionally examined for needle pull and they met the requirements.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.What is the name of the surgical procedure? what anatomical structure was the 662g ethilon suture used on? what tissue was the needle piece retained in? what is the size of the needle piece that was removed? if applicable, will product be returned, return date, tracking information? what is physician¿s opinion as to the etiology of or contributing factors to this event? what are the patient demographic info: age, gender, weight, bmi at the time of index procedure? what is the patient¿s current status?.

Event Description

It was reported that a patient underwent foot surgery on toe on (b)(6) 2018 and suture was used.The suture separated from the needle during use and was imbedded in the patient¿s tissue.An additional procedure was indicated to remove the needle.Additional information has been requested.

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.The following information was requested, but unavailable: what is the name of the surgical procedure? what anatomical structure was the 662g ethilon suture used on? what tissue was the needle piece retained in? what is the size of the needle piece that was removed? if applicable, will product be returned, return date, tracking information? what is physician¿s opinion as to the etiology of or contributing factors to this event? what are the patient demographic info: age, gender, weight, bmi at the time of index procedure? what is the patient¿s current status?.

• Brand Name: ETHILON SUTURE 18"(45CM) 4-0 BLK
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7260569
• MDR Text Key: 99604209
• Report Number: 2210968-2018-70778
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10705031007734
• UDI-Public: 10705031007734
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• 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,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 662G
• Device Lot Number: LAJ295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2017
• 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
• Patient Outcome(s): Required Intervention