InjuryHSB
FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1160-T-225
Received Jun 26, 2026
Report 9680825-2026-00030 · MDR key 25635278
Device
Generic name
Fitbone Intramedullary Lengthening Nail Taa1160-t-225
Manufacturer
Orthofix SrlModel number
FITBONECatalog number
60001445.
Product problems
- Patient Device Interaction Problem
Patient
NA · Female
- Medical device site infection
Narrative
Additional Manufacturer Narrative
DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED FOR INVESTIGATION, BUT IT HAS BEEN REQUESTED TO RETURN. IF THE DEVICE IS RETURNED AN INVESTIGATION WILL BE COMPLETED AND A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
AS PER THE REPORTER THE CABLE OF THE FITBONE NAIL HAS PERFORATED THE INFRAPATELLAR SCAR 6 WEEKS POST SURGERY. THE WOUND IS INFECTED. PATIENT NEEDS ANTIBIOTIC TREATMENT AND POSSIBLY RE-SURGERY.