Piccolo Composite Nailing System Tibial NailRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290109332390), received between Aug 31, 2017 and Aug 31, 2017 — 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 (K102369, K111056, K132774); 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.

• InjuryAug 31, 2017Fracture; Fracture

  THE INVOLVED PRODUCT (11 MM DIAMETER TIBIAL NAIL) WAS IMPLANTED ON (B)(6) 2016 IN A PATIENT (B)(6). ACCORDING TO THE INFORMATION PROVIDED TO THE COMPANY, PATIENT FELL WHILE HAVING A SEIZURE, AND NAIL BROKE. NAIL WAS REMOVED ON (B)(6) 2017, AND REPLACED WITH A LARGER NAIL OF ANOTHER COMPANY (OF 12 MM DIAMETER).

  Patient problems: Bone Fracture(s); Fall; Seizures

  MAUDE report 6833729 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102369, K111056, K132774. 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