NA 02.111.903.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982032522), received between Sep 27, 2022 and Sep 27, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT 2.0MM DRILL TIP WIRE BECAME STUCK IN CANNULATION OF COMPRESSION/DISTRACTION DEVICE. SURGEON WAS ABLE TO REMOVE THE WIRE WITH PLIERS BUT CANNULATION WAS UNUSABLE. CASE CONTINUED WITH ONLY USING WIRES IN 3 REMAINING HOLES OF COMPRESSION/DISTRACTION DEVICE. ON INSPECTION AFTER THE CASE THE WIRES IN THE SET ALL LOOKED HEAVILY USED AND BLUNT/BENT SO WERE DISCARDED. ULNA SHORTENING OSTEOTOMY. SURGERY WAS DELAYED FOR 5 MINUTES AND MORE. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT STATUS/ OUTCOME / CONSEQUENCES :NO. THIS REPORT IS FOR ONE (1)2.0MM K-WIRE W/DRILL TIP-150MM. THIS IS REPORT 8 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491370 ↗
• MalfunctionSep 27, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT 2.0MM DRILL TIP WIRE BECAME STUCK IN CANNULATION OF COMPRESSION/DISTRACTION DEVICE. SURGEON WAS ABLE TO REMOVE THE WIRE WITH PLIERS BUT CANNULATION WAS UNUSABLE. CASE CONTINUED WITH ONLY USING WIRES IN 3 REMAINING HOLES OF COMPRESSION/DISTRACTION DEVICE. ON INSPECTION AFTER THE CASE THE WIRES IN THE SET ALL LOOKED HEAVILY USED AND BLUNT/BENT SO WERE DISCARDED. ULNA SHORTENING OSTEOTOMY. SURGERY WAS DELAYED FOR 5 MINUTES AND MORE. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT STATUS/ OUTCOME / CONSEQUENCES :NO. THIS REPORT IS FOR ONE (1)2.0MM K-WIRE W/DRILL TIP-150MM. THIS IS REPORT 6 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491350 ↗
• MalfunctionSep 27, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT 2.0MM DRILL TIP WIRE BECAME STUCK IN CANNULATION OF COMPRESSION/DISTRACTION DEVICE. SURGEON WAS ABLE TO REMOVE THE WIRE WITH PLIERS BUT CANNULATION WAS UNUSABLE. CASE CONTINUED WITH ONLY USING WIRES IN 3 REMAINING HOLES OF COMPRESSION/DISTRACTION DEVICE. ON INSPECTION AFTER THE CASE THE WIRES IN THE SET ALL LOOKED HEAVILY USED AND BLUNT/BENT SO WERE DISCARDED. ULNA SHORTENING OSTEOTOMY. SURGERY WAS DELAYED FOR 5 MINUTES AND MORE. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT STATUS/ OUTCOME / CONSEQUENCES :NO. THIS REPORT IS FOR ONE (1)2.0MM K-WIRE W/DRILL TIP-150MM THIS IS REPORT 7 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491346 ↗
• MalfunctionSep 27, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT 2.0MM DRILL TIP WIRE BECAME STUCK IN CANNULATION OF COMPRESSION/DISTRACTION DEVICE. SURGEON WAS ABLE TO REMOVE THE WIRE WITH PLIERS BUT CANNULATION WAS UNUSABLE. CASE CONTINUED WITH ONLY USING WIRES IN 3 REMAINING HOLES OF COMPRESSION/DISTRACTION DEVICE. ON INSPECTION AFTER THE CASE THE WIRES IN THE SET ALL LOOKED HEAVILY USED AND BLUNT/BENT SO WERE DISCARDED. ULNA SHORTENING OSTEOTOMY. SURGERY WAS DELAYED FOR 5 MINUTES AND MORE. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT STATUS/ OUTCOME / CONSEQUENCES :NO THIS REPORT IS FOR ONE (1)2.0MM K-WIRE W/DRILL TIP-150MM THIS IS REPORT 4 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491317 ↗
• MalfunctionSep 27, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT 2.0MM DRILL TIP WIRE BECAME STUCK IN CANNULATION OF COMPRESSION/DISTRACTION DEVICE. SURGEON WAS ABLE TO REMOVE THE WIRE WITH PLIERS BUT CANNULATION WAS UNUSABLE. CASE CONTINUED WITH ONLY USING WIRES IN 3 REMAINING HOLES OF COMPRESSION/DISTRACTION DEVICE. ON INSPECTION AFTER THE CASE THE WIRES IN THE SET ALL LOOKED HEAVILY USED AND BLUNT/BENT SO WERE DISCARDED. ULNA SHORTENING OSTEOTOMY. SURGERY WAS DELAYED FOR 5 MINUTES AND MORE. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT STATUS/ OUTCOME / CONSEQUENCES :NO. THIS REPORT IS FOR ONE (1)2.0MM K-WIRE W/DRILL TIP-150MM. THIS IS REPORT 3 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491262 ↗

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