MalfunctionHSB
FITBONE TRANSPORT NAIL TN 1160-T-350 STERILE
Received Jun 30, 2026 · Event occurred Jun 8, 2026
Report 9680825-2026-00031 · MDR key 25664163
Device
Generic name
Fitbone Transport Nail Tn 1160-t-350 Sterile
Manufacturer
Orthofix SrlModel number
FITBONECatalog number
99-60003303
Product problems
- Mechanical Jam
Patient
27 YR · Male
- No Clinical Signs, Symptoms or Conditions
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
RECEIVED INFORMATION THAT ALLEGED A FITBONE TRANSPORT NAIL, TIBIA, DID NOT WORK DURING IMPLANT. THE NAIL WAS REMOVED AND A NEW NAIL WAS IMPLANTED. THE SURGERY WAS DELAYED BY 30 MINUTES.