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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); Difficult to Remove (1528)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/15/2020
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 during an open reduction internal fixation ankle fracture fibula repair the nail was inserted per technique, the surgeon did not like the position so he tried to remove it. During the removal it broke and the end cap remained in the patient. It was observed the talons of the implant were not open. The doctor replaced it with another nail and it was implanted with no issues but a portion of the first nail still remains in the patient. The procedure was completed. The doctor and the patient are planning to do a revision to remove the first partial nail.
 
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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 Key10366844
MDR Text Key201686163
Report Number1220246-2020-02004
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 company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 08/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
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 Number10584447
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/21/2020
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: 08/05/2020 Patient Sequence Number: 1
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