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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 Problems Break (1069); Failure to Advance (2524); Material Twisted/Bent (2981)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/04/2021
Event Type  malfunction  
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 the long flexible wire from the ar-8973ds fibulock implant system was introduced and advance up the fibula. When the 3. 2mm reamer was introduced and advanced up the fibula, the device came to a hard stop. When attempting to advance the 3. 2mm reamer up the fibula further, the flexible wire that was being reamed over broke in half. The broken flexible wire was left in the fibula and the ar-8973l-30-130 fibulock nail was inserted per technique guide. The proximal tip of the fibulock nail came into contact with the broken end of the wire and as the fibulock nail passed by the broken wire, the proximal tip of the fibulock bent. The fibulock nail and flexible wire were both left in the fibula as the fracture was reduced and the doctor did not have a problem leaving it in the patient.
 
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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 Key11547674
MDR Text Key243334198
Report Number1220246-2021-02771
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 Administrator/Supervisor
Type of Report Initial
Report Date 03/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFIBULOCK IMPLANT SYSTEM, STERILE
Device Catalogue NumberAR-8973DS
Device Lot Number10763386
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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