MAUDE Adverse Event Report: ARTHREX INC. SUREFIRE SCORPION NEEDLE; NEEDLE, SUTURING, DISPOSABLE

Catalog Number REF AR-13991N

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 03/20/2018

Event Type  malfunction  

Event Description

Needle tip broke during use.

• Brand Name: SUREFIRE SCORPION NEEDLE
• Type of Device: NEEDLE, SUTURING, DISPOSABLE
• Manufacturer (Section D): ARTHREX INC.
• MDR Report Key: 7494044
• MDR Text Key: 107822508
• Report Number: MW5077045
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: REF AR-13991N
• Device Lot Number: 10113536
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 65