Piccolo Composite Nailing System Lag Screw (REF PPFLS10080)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290109335452), received between Aug 31, 2017 and Aug 31, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionAug 31, 2017Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component; Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component

  DURING IMPLANTATION OF A PICCOLO COMPOSITE PF NAIL AND SCREWS, THE SURGEON DECIDED TO REPLACE THE LAG SCREW WHICH WAS JUST INTRODUCED WITH A LONGER ONE. UPON REMOVING THE LAG SCREW FROM THE BONE, THE SCREW' TITANIUM SHELL REMAINED IN THE BONE. ANOTHER LAG SCREW WAS USED, THREADED INTO THE REMAINING TITANIUM SHELL. THE OPERATION WAS SATISFACTORILY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6833850 ↗

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