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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
Model Number 3.0X130MM FIBULA NAIL, LEFT
Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/08/2019
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has 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 a left ankle fracture procedure, the proximal end of the fib30130l fibula nail broke off during insertion and was left inside of the fibula. The rep stated the fracture was successfully reduced and fixated with a distal fibula plate and screws. The seated depth of the implant was 130mm. A 3. 22mm was used to prep the bone. Additional information has been requested. Additional information received on (b)(6) 2019: the rep stated that the surgeon attempted to remove the broken fragment, but no avail. The rep confirmed the remaining portion of the nail was retrieved and will be returning for evaluation. The bone was prepped by using a 6. 2 distal reamer and 3. 2 proximal reamer. The rep stated that the surgeon had to switch to their back up plan to make a larger incision so they could plate the fracture. A second fib30130l was not brought in. The case was completed by using an ankle fracture plate.
 
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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
8009337001
MDR Report Key8479859
MDR Text Key140814239
Report Number1220246-2019-00998
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
Type of Report Initial,Followup
Report Date 04/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2019
Device Model Number3.0X130MM FIBULA NAIL, LEFT
Device Catalogue NumberFIB30130L
Device Lot NumberA091117-08
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/03/2019 Patient Sequence Number: 1
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