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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX INC. ARTHREX SCORPION -MULTI FIRE NEEDLE NEEDLE, SUTURING, DISPOSABLE

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ARTHREX INC. ARTHREX SCORPION -MULTI FIRE NEEDLE NEEDLE, SUTURING, DISPOSABLE Back to Search Results
Lot Number 12300015
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/12/2021
Event Type  Injury  
Event Description
When placing the suture with the scorpion needle the surgeon observed that the needle tip broke off of the scorpion needle. The surgeon tried to retrieve the tip of the scorpion needle but was unsuccessful. Fda safety report id# (b)(4).
 
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Brand NameARTHREX SCORPION -MULTI FIRE NEEDLE
Type of DeviceNEEDLE, SUTURING, DISPOSABLE
Manufacturer (Section D)
ARTHREX INC.
MDR Report Key11515205
MDR Text Key241035504
Report NumberMW5100097
Device Sequence Number1
Product Code GAB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number12300015
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: 03/17/2021 Patient Sequence Number: 1
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