LCP 03.111.905Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982072634), received between Dec 6, 2021 and Jun 3, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SAW GUIDE WILL NOT ATTACH TO THE DRILL TEMPLATES. THERE WAS NO SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) SAW GUIDE FOR 2.7MM LCP ULNA OSTEOTOMY PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448644 ↗
• MalfunctionMar 2, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE THE PIECE WAS BEING TIGHTENED, JUST AS IT HAS OTHER TIMES AND IT BROKE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. SURGICAL DELAY IS UNKNOWN. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THE COMPLAINT INVOLVES (1) DEVICE SAW GUID F/LCP ULN OSTEOT PL 2.7. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653123 ↗
• MalfunctionDec 6, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE THREADED SCREW THAT ATTACHED THE 45 DEGREE CUTTING BLOCK TO THE DRILL TEMPLATE OFF THE ULNA SHORTENING OSTEOTOMY SET SNAPPED IN HALF WHEN SURGEON WAS THREADING THE TWO PIECES TOGETHER. SURGEON HAD TO USE A 1.0 K-WIRE TO LOOSELY SECURE THE GUIDE BLOCK TO THE DRILL TEMPLATE. THERE WAS A TEN (10) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) SAW GUIDE FOR 2.7MM LCP ULNA OSTEOTOMY PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12938218 ↗

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