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

Lot Number 10225022

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/25/2018

Event Type  malfunction  

Event Description

During the right shoulder arthroscopic revision of rotator cuff repair, when passing the suture through the tendon, the tip of the scorpion needle broke off in the rotator cuff.Surgeon attempted to retrieve it but could not.Said risks outweighed the benefits so he left it in.Tip was approximately 3mm.No harm to pt.And this was disclosed by surgeon.

• 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: 8105462
• MDR Text Key: 128456653
• Report Number: 8105462
• 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: 11/19/2018,11/13/2018

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: No Information
• Device Lot Number: 10225022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2018
• Date Report to Manufacturer: 11/27/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19345 DA