Piccolo Composite Nailing System Proximal Femur Nail (REF PPFR11320)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290109336480), received between Jul 19, 2018 and Jul 19, 2018 — 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

Recent adverse event reports

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

• InjuryJul 19, 2018Fracture; Fracture

  A PICCOLO COMPOSITE PF NAIL WAS IMPLANTED TO TREAT A PATHOLOGIC FRACTURE. ABOUT 3 WEEKS AFTER IMPLANTATION, THE NAIL BROKE AND WAS REPLACED. BASED ON THE X-RAYS PROVIDED TO THE COMPANY, THE CASE INVOLVED SIGNIFICANT BONE LOSS WITH LARGE FRACTURE GAP.

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

  MAUDE report 7702063 ↗

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