Piccolo Composite Nailing System Lag Screw (REF PPFLS10095)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290109337852), received between Jun 15, 2021 and Jun 15, 2021 — 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.

• MalfunctionJun 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING IMPLANTATION OF A PICCOLO COMPOSITE PF NAIL IN (B)(6), AFTER LAG SCREW INSERTION AND X-RAY EXAMINATION, THE SURGEON DECIDED TO REMOVE THE LAG SCREW AND REPLACE IT WITH A SHORTER LAG SCREW SINCE IT WAS TOO LONG. AFTER LAG SCREW REMOVAL, THE SURGEON DISCOVERED THAT THE TITANIUM SHELL AT THE LAG SCREW DISTAL END SEPARATED FROM THE LAG SCREW AND REMAINED IN THE BONE. A SHORTER LAG SCREW WAS INSERTED WITH SHELL REMAINING IN SITU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11997309 ↗

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