MAUDE Adverse Event Report: ETHICON INC. NYLON BLACK 2-0 45CM(1)SC30; SUTURE, NONABSORBABLE

Catalog Number NM103X

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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 a patient underwent a breast prosthesis procedure on (b)(46 2017 and suture was used.The suture may have ruptured during the procedure and/ or pulled off from the needle.No adverse patient outcome was reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Unopened representative samples were received for analysis.During the visual inspection of samples, the package, swage and attachment area were as expected.The test for diameter, length, strength and pull test and fully meets the material specification.According to the sample condition, no damage product, breakage suture or pull off suture needle and the tested sample met the finished goods requirements.

• Brand Name: NYLON BLACK 2-0 45CM(1)SC30
• Type of Device: SUTURE, NONABSORBABLE
• 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
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7338507
• MDR Text Key: 102386661
• Report Number: 2210968-2018-71434
• 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: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: NM103X
• Device Lot Number: AJ4067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• 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