MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number AR-13995N

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/09/2018

Event Type  malfunction  

Event Description

Arthrex scopion needle broke intra-operatively.Tip of needle unable to be retrieved.

• Brand Name: ARTHREX
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd.; naples FL 34108
• MDR Report Key: 7968668
• MDR Text Key: 123819821
• Report Number: 7968668
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/10/2018

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: Health Professional
• Device Model Number: AR-13995N
• Device Catalogue Number: AR-13995N
• Device Lot Number: 10225311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30295 DA