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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. SCORPION-MULTIFIRE NEEDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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ARTHREX, INC. SCORPION-MULTIFIRE NEEDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Back to Search Results
Model Number SCORPION-MULTIFIRE NEEDLE
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/06/2022
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
On (b)(6) 2022, it was reported by medwatch via email that an ar-13995n multifire scorpion needle tip broke off leaving a 1mm piece of metal embedded in the tendon.This was discovered during an unspecified procedure (b)(6) 2022.
 
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Brand Name
SCORPION-MULTIFIRE NEEDLE
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 Key15743116
MDR Text Key307598337
Report Number1220246-2022-05704
Device Sequence Number1
Product Code MDM
UDI-Device Identifier00888867015951
UDI-Public00888867015951
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSCORPION-MULTIFIRE NEEDLE
Device Catalogue NumberAR-13995N
Device Lot Number14970439
Was Device Available for Evaluation? No
Date Manufacturer Received10/18/2022
Date Device Manufactured06/13/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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