• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX ARTHREX SCORPION

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARTHREX ARTHREX SCORPION Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARTHREX
Type of DeviceSCORPION
Manufacturer (Section D)
ARTHREX
MDR Report Key6030363
MDR Text Key57602984
Report NumberMW5065393
Device Sequence Number1
Product Code HRX
Reporter Country CodeUS
Number of Events Reported1
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 Received10/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/12/2016 Patient Sequence Number: 1
-
-