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

Model Number RB-1 4-0

Device Problems Break (1069); Component Falling (1105)

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

Event Date 06/21/2017

Event Type  malfunction  

Event Description

The needle broke - part was still with the suture and part of the needle broke off.

• Brand Name: MONOCRYL
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON, INC.; route 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 6720739
• MDR Text Key: 80272600
• Report Number: 6720739
• Device Sequence Number: 1
• Product Code: GAM
• 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: 06/21/2017,06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: RB-1 4-0
• Device Catalogue Number: Y214H
• Device Lot Number: LCM162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2017
• 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: 29 YR