MAUDE Adverse Event Report: ETHICON INC. ETHILON*BLACK3-0 45CM (1)SC-30; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 1171T

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Please clarify the event "the thread pulled off from the needle": was the thread found detached from the needle while in the package? did the thread detach from the needle before use on patient? did the thread detach from the needle during use on patient? did the needle fall into the patient? was the needle removed in the same procedure? was additional tissue incision required to remove the needle? the device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

Event Description

It was reported that during an unknown procedure on (b)(6) 2017, the thread of the suture pulled off from the needle.There were no adverse patient consequences.Additional information has been requested.

Manufacturer Narrative

An opened secondary package, a paper folder and a broken suture were returned for analysis.During the visual inspection of the sample under 10x magnification, the swage and attachment area were as expected.Additionally, the thread still in the needle.The suture was inspected along of the strand, and the broken suture were noted.In addition, crushing mark were found, near to the thread broken, that appears to be by a surgical instrument.Functionality diameter and knot tensile tests meet the requirements, the length test couldn¿t be performed as the sample was returned used.When handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.

• 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. - BRAZIL; rodovia presidente dutra; km 154; sao paolo ; BR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7088765
• MDR Text Key: 94504717
• Report Number: 2210968-2017-71637
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• 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: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 1171T
• Device Lot Number: AH5448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR