MAUDE Adverse Event Report: ETHICON, INC. MONOCRYL; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y497G

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

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

Event Date 07/27/2016

Event Type  malfunction  

Event Description

The surgeon was using a suture needle to close a patient at the conclusion of a procedure.While closing, the needle broke in two pieces, both pieces were retrieved.The patient was not harmed.

• Brand Name: MONOCRYL
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON, INC.; 3348 pulliam st.; san angelo TX 76905
• MDR Report Key: 6053985
• MDR Text Key: 58293983
• Report Number: 6053985
• Device Sequence Number: 1
• Product Code: GAN
• 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: 08/15/2016,08/16/2016

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: No Information
• Device Catalogue Number: Y497G
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2016
• 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: 74 YR
• Patient Weight: 82