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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. SCORPION NEEDLE, KNEE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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ARTHREX, INC. SCORPION NEEDLE, KNEE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Back to Search Results
Model Number SCORPION NEEDLE, KNEE
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Insufficient Information (4580)
Event Date 10/28/2022
Event Type  malfunction  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
It was reported on (b)(6) 2022 by a sales representative via sems that an ar-12990n scorpion needle broke off.Case involvement, broke inside joint space.
 
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Brand Name
SCORPION NEEDLE, KNEE
Type of Device
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key15870611
MDR Text Key307668137
Report Number1220246-2022-05809
Device Sequence Number1
Product Code MDM
UDI-Device Identifier00888867199354
UDI-Public00888867199354
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSCORPION NEEDLE, KNEE
Device Catalogue NumberAR-12990N
Device Lot Number14379279
Was Device Available for Evaluation? No
Date Manufacturer Received11/07/2022
Date Device Manufactured10/21/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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