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Piccolo Composite Nailing System Proximal Femur Nail (REF PPFL11320)Recalls & reported problems

Carbofix Orthopedics Ltd · Nail indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric, high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, malunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures. · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290109336404), received between Aug 15, 2022 and Aug 15, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

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

Device problems

  • Fracture1

Patient problems

  • Nonunion/Delayed-union Bone Fracture1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 15, 2022Fracture; Fracture

    A CANCER PATIENT WITH AN ONCOLOGICAL LESION IN THE FEMORAL AREA UNDERWENT PF NAIL IMPLANTATION SURGERY IN (B)(6) FOR IMPENDING FRACTURE. THE WEIGHT OF THE PATIENT WAS 95 KG, HEIGHT 1.57 METERS. ABOUT TWO MONTHS POST-OPERATIVELY, THE PATIENT WAS DELIVERED TO THE EMERGENCY ROOM. X-RAY TAKEN REVEALED AN ATRAUMATIC PERI-IMPLANT FRACTURE ABOVE THE NAIL, AND DID NOT INDICATE THAT THE NAIL WAS BROKEN. AFTER THREE DAYS A REVISION SURGERY WAS CONDUCTED, DURING WHICH IT WAS SHOWN THAT THE NAIL WAS BROKEN AT THE MID-SHAFT AREA. THE FRACTURED NAIL WAS EXTRACTED AND REPLACED.

    Patient problems: Nonunion/Delayed-union Bone Fracture

    MAUDE report 15223663 ↗

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

Other Rod, Fixation, Intramedullary And Accessories devices

All Rod, Fixation, Intramedullary And Accessories devices →

Sources and updates

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