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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. 3.0X130MM FIBULA NAIL, RIGHT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ARTHREX, INC. 3.0X130MM FIBULA NAIL, RIGHT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3.0X130MM FIBULA NAIL, RIGHT
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 12/23/2020
Event Type  Injury  
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.
 
Event Description
It was reported, that during an ankle fracture repair procedure, during insertion of the ar-8972r-30-130 the proximal talons opened prior to deployment with the driver. The surgeon tried to tap with the impactor however, still a lot of resistance. The surgeon removed the ar-8972r-30-130, used the white handled driver to disengaged the talons, until they were flush with the shaft. The surgeon inserted the same ar-8972-30-130 and the same problem occurred. The ar-8972r-30-130 was logged and the talons broke off. The surgeon removed the ar-8972-30-130 unable to retrieve the broken talon. The surgeon used the same insertion site and completed the case using a different ar-8972r-30-130.
 
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Brand Name3.0X130MM FIBULA NAIL, RIGHT
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key11186228
MDR Text Key227486187
Report Number1220246-2021-02476
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173656
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3.0X130MM FIBULA NAIL, RIGHT
Device Catalogue NumberAR-8973R-30-130
Device Lot Number11473940
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/18/2021 Patient Sequence Number: 1
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