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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX MULTIFIRE SCORPION NEEDLE ARTHROSCOPE

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ARTHREX MULTIFIRE SCORPION NEEDLE ARTHROSCOPE Back to Search Results
Catalog Number AR-13995N
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/26/2016
Event Type  malfunction  
Event Description
Patient was undergoing a left shoulder rotator cuff repair. When the surgeon was passing the posterior sutures the scorpion felt uncomfortable and felt like it was impinges some and when it was removed, the very tip of the needle had broken. Surgeon estimates that approximately 2 mm of the needle broke. The operative site was inspected and no needle was found. Intraop x-rays showed no needle however the post-op x-ray showed a small needle fragment was retained in the patient. The surgeon felt this will not cause any future problems for the patient.
 
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Brand NameMULTIFIRE SCORPION NEEDLE
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
ARTHREX
naples FL 34106
MDR Report Key5403643
MDR Text Key37351013
Report NumberMW5059823
Device Sequence Number1
Product Code HRX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Catalogue NumberAR-13995N
Device Lot Number401145
Was Device Available for Evaluation? No Answer Provided
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

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