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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX MULTIFIRE SCORPION NEEDLE SUTURE NEEDLE

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ARTHREX MULTIFIRE SCORPION NEEDLE SUTURE NEEDLE Back to Search Results
Model Number AR-13995N
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 11/07/2017
Event Type  Injury  
Event Description
Pt diagnosed with complete tear of right rotator cuff. Pt scheduled for right rotator cuff repair surgery. While suturing the pt post right shoulder surgery, the scorpion needle was noted to break. However, this was retrieved in its entirety without complication. No harm to the pt. Area dressed. The surgeon denies using any excessive force to pass the needle, nor did he meet any resistance. This is a single use disposable item; it is not re-sterilized or reused.
 
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Brand NameMULTIFIRE SCORPION NEEDLE
Type of DeviceSUTURE NEEDLE
Manufacturer (Section D)
ARTHREX
MDR Report Key7024662
MDR Text Key91933854
Report NumberMW5073255
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAR-13995N
Device Lot Number10133914
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?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/13/2017 Patient Sequence Number: 1
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