MAUDE Adverse Event Report: ETHICON INC. ETHILON*BLACK 6-0 45CM (1)J-15; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 13500T

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2018

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.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.

Event Description

It was reported that during a rhinoplasty procedure on (b)(6) 2018, suture was used on the patient.During the procedure, the needle pulled off from thread during use.There were no patient consequences.

Manufacturer Narrative

It was reported that the needle pull off from thread.An overwrap package, a broken needle and a piece suture were returned for analysis.During the visual inspection of the sample, it was noted that the needle was missing the swage area (portion of the needle that attaches to the suture).In addition marks at the body of the broken needle could be observed.Looking at the needle under 10x magnification, several markings were noted were the needle was fractured.This damage is consistent with the material being over-stressed during use.The needle was functionally tested using bending resistance to confirm ductility and all results met manufacturing requirements.As the needle piece that contains the swage was not return for analysis, needle pull off couldn't be confirmed.

• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON BRAZIL; rodovia presidente dutra; km 154; sao paolo ; BR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7414655
• MDR Text Key: 105400272
• Report Number: 2210968-2018-72055
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K946173
• 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: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 13500T
• Device Lot Number: AJ8577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2018
• Date Device Manufactured: 02/01/2017
• 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