LCP 03.111.903Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982072610), received between Jan 19, 2018 and Jan 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Disassembly” (1 report).

1 other recall cover devices cleared under the same FDA submission (K113364); 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 16, 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.

• MalfunctionJan 19, 2018Disassembly; Disassembly

  IT WAS REPORTED THAT A 4MM DRILL TEMPLATE HAS A WIRE STUCK IN THE PROXIMAL HOLE. A COMPRESSION/DISTRACTION INSTRUMENT HAS A WIRE STUCK IN ONE OF THE HOLES AND A TIGHTEN WHEEL FELL OFF AND BROKE. IT WAS ALSO NOT COMPRESSING CORRECTLY WHEN THE K-WIRES ARE PLACED AND WHEN BEING COMPRESSED; THE TOP WILL COMPRESS, HOWEVER, AT THE BOTTOM BY THE BONE, STAYS THE SAME. THIS WAS DISCOVERED BY THE SURGICAL TECH ON THE BACK TABLE OF THE OPERATION ROOM. THERE IS NO REPORT OF PATIENT HARM OR SURGICAL DELAY. THERE IS ONE DEVICES IN THIS COMPLAINT. THIS REPORT IS 1 OF 1 FOR (B)(4). THIS COMPLAINT INVOLVES ONE (1) DEVICE. CONCOMITANT DEVICES REPORTED: K-WIRES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7206371 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113364. One submission often covers many models, so check the product and lot details in each record.

• Z-1274-2014 · Jan 7, 2014 · Terminated
  Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bon