MAUDE Adverse Event Report: ETHICON INC. MONOCRYL ABS SUR SUT SYN; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number NW1205

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.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.Did all 3 devices had issue during the same procedure? if the issue occurred during same procedure,please indicate for each device, what was the issue with each device, needle breakage or suture needle pull off? when did issue occur? nw838 lot b5005, nw833 lot b7002 , nw1205 lot tmv02.How was case completed? any patient consequences? if yes, what medical/surgical intervention was provided?.

Event Description

It was reported that a patient underwent a hernia repair procedure on (b)(6) 2018 and suture was used.During the procedure, the needle was breaking from middle and suture came out from the swaging point.There were no adverse patient consequences reported.Additional information has been requested.

Manufacturer Narrative

(b)(4).The device was not returned and the product lot number was not available.Therefore no further investigation, product analysis and process review could not be established.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.Lot number tmv02 is not a valid lot number for product code nw1205.Please provide correct lot number if available.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.Additional information was requested and the following was obtained: what was the issue with each device, needle breakage or suture needle pull off? when did issue occur? (b)(4) - suture came out from the swaging point of the needle.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.The new information states (b)(4) is only a needle pull off.Please confirm this is correct.Prior information states the had both needle breakage and needle pull off.Please confirm what is correct.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: investigation summary: we received 3 opened complaint sample as 3 zipper trays, 3 lids, 3 needles and suture pieces.Complaint sample foil was not returned for investigation.Sutures received in partial disintegrated condition.Returned needles were visually inspected, upon 10x magnification found to be satisfactory.The product lot no.Was not available on the complaint sample or complaint email.Therefore in the absence of the lot no.Further investigation, product analysis and process review could not be established.

• Brand Name: MONOCRYL ABS SUR SUT SYN
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7450914
• MDR Text Key: 106262870
• Report Number: 2210968-2018-72263
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/26/2018

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 Catalogue Number: NW1205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 05/14/2018; 07/04/2018; 10/31/2018
• Supplement Dates FDA Received: 06/06/2018; 07/31/2018; 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1