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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX SCORPION MULTIFIRE NEEDLE ARTHROSCOPE

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ARTHREX SCORPION MULTIFIRE NEEDLE ARTHROSCOPE Back to Search Results
Catalog Number AR-13995N
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/15/2018
Event Type  malfunction  
Event Description
During arthroscopic shoulder surgery, a small piece of the tip of an arthrex scorpion multifire needle broke off in pt's shoulder. Surgeon stated that it was "irretrievable" and informed pt's family and pt, of event.
 
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Brand NameSCORPION MULTIFIRE NEEDLE
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
ARTHREX
munchen 81249 DE
GM 81249 DE
MDR Report Key7240977
MDR Text Key99098131
Report NumberMW5075058
Device Sequence Number1
Product Code HRX
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 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAR-13995N
Was Device Available for Evaluation? No
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: 02/02/2018 Patient Sequence Number: 1
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