MAUDE Adverse Event Report: ETHICON INC. ETHILON* BLK 4-0 45 (1)PS-1 PR; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number P1664T

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2018

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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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 when the needle pulled off from the thread: - while in the package.- when removing from the package.- during use on patient.

Event Description

It was reported that a patient underwent plastic surgery procedure on (b)(6) 2018 and suture was used.The thread detached from the needle.Another similar product was used to complete the procedure.There were no adverse patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent to fda: 9/21/2018 additional evaluation summary: the actual sample was returned for analysis.During the visual inspection of the sample, the swage and attachment area were as expected in the loose needle.Additionally, no thread residue was found in the hole needle.However, the suture was knotted and the suture end of the suture was found broken and with pinch marks near to the broken area appears to be by the use of a surgical instrument.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.According to the samples condition, the assignable cause is due to improper handling of the sample.When handling this or any other suture material, care should be taken to avoid damage from handling.

• 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 INC.-BRAZIL; rodovia presidente dutra; km 154; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7814039
• MDR Text Key: 118403568
• Report Number: 2210968-2018-75407
• 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: 07/30/2018

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 Expiration Date: 12/31/2022
• Device Catalogue Number: P1664T
• Device Lot Number: AK1594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/24/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1