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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 Foreign Body In Patient (2687)
Event Date 08/26/2022
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 a sales representative via sems that an ar-13995n scorpion needle tip broke inside the patient.The surgeon was not able to retrieve the needle from the patient.
 
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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 Key15401940
MDR Text Key300142763
Report Number1220246-2022-05482
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 Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 09/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2022
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 Number14549405
Was Device Available for Evaluation? No
Date Manufacturer Received08/26/2022
Date Device Manufactured11/16/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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