Piccolo Composite Nailing System Proximal Femur Nail (REF PPFR11420)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109336534), received between May 6, 2020 and Mar 25, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K151010, K153536); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Fracture

  ON MARCH 16, 2026, THE COMPANY BECAME AWARE OF A CASE INVOLVING ITS PICCOLO COMPOSITE PF NAIL. BASED ON THE INFORMATION PROVIDED TO THE COMPANY, THE DEVICE WAS IMPLANTED IN AN ONCOLOGIC PATIENT WITH FEMORAL METASTASES ON (B)(6) 2024, FOLLOWING A FALL RESULTING IN A PATHOLOGICAL FRACTURE OF THE FEMUR. APPROXIMATELY FIVE MONTHS POST-IMPLANTATION, THE NAIL FRACTURED AT OR NEAR THE LAG SCREW INTERFACE DUE TO NON-UNION. ON (B)(6) 2025, THE NAIL WAS REMOVED AND REPLACED WITH A TOTAL HIP PROSTHESIS.

  Patient problems: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture

  MAUDE report 24686360 ↗
• InjuryMay 6, 2020Fracture; Fracture

  A PROXIMAL FEMUR NAIL WAS IMPLANTED TO TREAT A PATHOLOGIC FRACTURE (ONCOLOGICAL PATIENT) IN (B)(6). MORE THAN 9 MONTHS POST-OPERATION, NAIL BROKE AT THE SUB-TROCHANTERIC AREA AND WAS REPLACED WITH A METAL NAIL IN A REVISION SURGERY.

  Patient problems: Hip Fracture

  MAUDE report 10028610 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151010, K153536. One submission often covers many models, so check the product and lot details in each record.

• Z-1991-2016 · May 10, 2016 · Terminated
  Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being