Piccolo Composite Nailing System Lag Screw (REF PPFLS10100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109335476), received between Jul 4, 2018 and May 21, 2020 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2020Material Separation; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Separation; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  DURING IMPLANTATION OF A PICCOLO COMPOSITE PF NAIL IN (B)(6), AFTER LAG SCREW INSERTION, THE SURGEON WANTED TO SLIGHTLY UNSCREW THE LAG SCREW SINCE IT WAS INSERTED TOO DEEP. DURING UNSCREWING OF THE LAG SCREW THE TITANIUM SHELL AT THE LAG SCREW DISTAL END SEPARATED FROM THE LAG SCREW AND REMAINED IN THE BONE. THE SURGERY WAS CONVERTED TO A TOTAL HIP REPLACEMENT.

  Patient problems: No Code Available

  MAUDE report 10077993 ↗
• MalfunctionJul 4, 2018Use of Device Problem; Use of Device Problem

  A PICCOLO COMPOSITE PF LAG SCREW WAS DAMAGED DURING IMPLANTATION. ANOTHER SCREW WAS USED AND THE OPERATION WAS SATISFACTORILY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7662205 ↗

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