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U.S. Department of Health and Human Services

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

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ARTHREX INC. 3.0X130MM FIBULA NAIL, LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number FIB30130L
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/30/2018
Event Type  Injury  
Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided. No further patient information was provided at the time of this report or made available in response to follow-up communication. No additional adverse consequences have been reported from this event. This device is used for treatment. The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The cause of the event could not be determined from the information available and without device evaluation. The device history record review revealed nothing relevant to the event. If the device is returned and additional information is obtained, a follow-up report will be submitted. The potential causes of this event are being communicated to the event reporter. If additional relevant information is received, a follow-up report will be submitted.
 
Event Description
It was reported that during a distal fibula fracture procedure, the surgeon drilled with the 6. 2 mm and then the 3. 2 mm drills from the fibulock disposable kit, placed cannula, proceeded to place the nail by hand, but realized he should have drilled a bit further. He pulled the nail back out of the fibula with ease, but the talons stayed in the fibula. He was able to re-drill and place a new nail, which turned out great, but the extra talons stayed in the patient. No attempts were made to remove the talon/top piece of the device.
 
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Brand Name3.0X130MM FIBULA NAIL, LEFT
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, adverse events
1370 creekside boulevard
naples, FL 34108-1945
8009337013
MDR Report Key7540109
MDR Text Key109113857
Report Number1220246-2018-00191
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160069
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2019
Device Catalogue NumberFIB30130L
Device Lot NumberAO61117-03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2017
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: 05/24/2018 Patient Sequence Number: 1
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