MAUDE Adverse Event Report: ARTHREX ARTHREX; SCORPION

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2016

Event Type  Injury  

Event Description

Procedure: repair of shoulder superior labrum anterior lesion, subacromial decompression, arthroscopic distal resection.Surgeon was inserting the labral scorpion into the shoulder during surgery, it was noted that the top part of the scorpion had broken off into the shoulder.The surgeon was able to retrieve the piece.No harm to the pt.

• Brand Name: ARTHREX
• Type of Device: SCORPION
• Manufacturer (Section D): ARTHREX
• MDR Report Key: 6030363
• MDR Text Key: 57602984
• Report Number: MW5065393
• Device Sequence Number: 1
• Product Code: HRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR