Piccolo Composite Nailing System Lag Screw (REF PPFLS10090)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290109335469), received between Oct 3, 2017 and Oct 3, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionOct 3, 2017Break; Use of Device Problem; Torn Material; Break; Use of Device Problem; Torn Material

  DURING IMPLANTATION OF A PICCOLO COMPOSITE PROXIMAL FEMUR NAIL IN (B)(6), A LAG SCREW BROKE. IN THE TIME OF THE SCREW INSERTION, THE SURGEON FELT RESISTANCE AND DECIDED TO EXTRACT THE SCREW IN ORDER TO REPEAT THE DRILLING. DURING UNSCREWING, THE DISTAL TIP OF THE SCREW BROKE AND THE SURGEON EXTRACTED THE SCREW LEAVING THE DISTAL END IN SITU. ANOTHER CARBOFIX LAG SCREW WAS INSERTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant

  MAUDE report 6910021 ↗

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