MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Did the operating surgeon observe any suture deficiency or anomaly before, during or after its use in the patient? did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? when did the needle pull off (while in the package / during dispensing / during preparation / during use)? what is the number of devices where the needle pulled off from the suture? did this occur in multiple patient procedures? if so: what is the number of patient procedures were any of these events previously reported to ethicon? what was the name of the procedure? what is the date of the procedure? is the product or representative sample (product from the same lot number) available for evaluation? can you identify the product code(s) and lot number(s) of the product that was used? the single complaint was reported with multiple events.There are no additional details regarding the additional events.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.

Event Description

It was reported that the patient underwent an unknown procedure on unknown date and the unknown suture was used.During the procedure, the needle came off the suture.Additional information has been requested.

• Brand Name: SUTURE UNKNOWN
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6401298
• MDR Text Key: 70085165
• Report Number: 2210968-2017-31144
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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