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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. FIBULOCK IMPLANT SYSTEM, STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ARTHREX, INC. FIBULOCK IMPLANT SYSTEM, STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number FIBULOCK IMPLANT SYSTEM, STERILE
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/10/2019
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 retrieved portion of the device was reported to have been discarded. 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 fx procedure, as the surgeon was inserting the guidewire that's included in the fibulock implant system, ar-8793ds, the gold tip broke off. The tip was unable to be retrieved from the patient as it was lodged within the bone canal. As the surgeon attempted to insert the fibluock nail, he found difficulty reaming past the broken fragment. He was eventually able to push the fragment to the side and insert the fibulock nail. A delay of approximately 20 min incurred due to the broken fragment.
 
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Brand NameFIBULOCK IMPLANT SYSTEM, STERILE
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 Key9289814
MDR Text Key182469708
Report Number1220246-2019-01401
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 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFIBULOCK IMPLANT SYSTEM, STERILE
Device Catalogue NumberAR-8973DS
Device Lot Number10342579
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/25/2019
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: 11/07/2019 Patient Sequence Number: 1
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