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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX MANUFACTURING INC. ARTHREX FIBULOCK ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ARTHREX MANUFACTURING INC. ARTHREX FIBULOCK ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 11/11/2021
Event Type  Injury  
Event Description
Patient presented with a distal fibula fracture and associated syndesmosis disruption. Was initially treated with arthrex fibula nail aka fibulock and tightrope xp. Nail was broken within 12 days. To remove nail, large amounts of bone had to be removed and a large incision followed by a implanting a plate as a replacement treatment. Fda safety report id# (b)(4).
 
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Brand NameARTHREX FIBULOCK
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
ARTHREX MANUFACTURING INC.
MDR Report Key12820556
MDR Text Key280902831
Report NumberMW5105349
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/15/2021 Patient Sequence Number: 1
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