MAUDE Adverse Event Report: ETHICON, INC. ETHILON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number 10-0

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2017

Event Type  malfunction  

Event Description

Suture needles have been popping off the suture (they are not "pop offs" ) before surgeon is finished using them.Suture needles are very small, and if they fall off and are not caught by surgeon or nurse, it will be very difficult to find them.Luckily, in this situation the scrub rn did not lose any needles during the case.10-0 nylon ethicon, ref # (b)(4), exp date 11/30/2021.

• Brand Name: ETHILON
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON, INC.; route 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 6934911
• MDR Text Key: 88861652
• Report Number: 6934911
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2021
• Device Model Number: 10-0
• Device Catalogue Number: 9000G
• Device Lot Number: KPZ334
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 66