FIBUNAIL
Received Jun 12, 2025 · Event occurred May 16, 2025
Report 1051526-2025-00001 · MDR key 22196374
Device
Generic name
Targeting Guide, Fibula Nail
Manufacturer
Vilex, LlcModel number
ZF-TARGCatalog number
ZF-TARG
Lot number
10971
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
UPON RECEIPT OF THE SUSPECTED GUIDE ASSEMBLY, VILEX WAS ABLE TO ASSEMBLE THE GUIDE WITH THE SAME SIZE NAIL IMPLANT USED WHEN THE EVENT OCCURRED. VILEX ATTEMPTED TO RECREATE THE SAME FAILURE DESCRIBED BY THE INITIAL REPORTER AND WAS UNABLE TO RECREATE THE EVENT.
Description of Event or Problem
VILEX WAS MADE AWARE OF THE EVENT ON 5/19/2025.DURING A FIBULA FRACTURE SURGERY, THE FIBULA NAIL TARGETING GUIDE WAS ASSEMBLED AND SUCCESSFULLY IMPLANTED THE NAIL. THE GUIDE WAS USED TO DRILL THE HOLES FOR THE CROSS SCREWS, HOWEVER THE HOLES WERE MISALIGNED AND THE SCREWS MISSED THE NAIL WHEN IMPLANTED. FOUR SCREWS WERE ATTEMPTED FROM THE ANTERIOR TO POSTERIOR POSITION AND ALL WERE UNSUCCESSFUL. ONE SCREW (INSERTED FROM LATERAL TO MEDIAL POSITION) WAS SUCCESSFULLY IMPLANTED INTO THE NAIL. OVERALL DELAY IN SURGERY WAS 2 HOURS WITH A LONGER INCISION AT THE SURGERY SITE.