NA 02.111.902.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982032492), received between Sep 19, 2022 and Jan 17, 2024 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE K-WIRE GOT STUCK IN A DRILL TEMPLATE. THE SURGEON CHOSE ANOTHER DRILL TEMPLATE TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WERE NO DELAYS. THIS REPORT INVOLVES ONE 2.0MM KIRSCHNER WIRE W/ DRILL TIP/100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18528412 ↗
• MalfunctionSep 27, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON SEPTEMBER 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 KIRSCHNER WIRE W/ DRILL TIP/100MM. THIS IS REPORT 11 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491433 ↗
• 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 KIRSCHNER WIRE W/ DRILL TIP/100MM. THIS IS REPORT 9 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491398 ↗
• MalfunctionSep 27, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON SEPTEMBER 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 KIRSCHNER WIRE W/ DRILL TIP/100MM THIS IS REPORT 10 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491325 ↗
• 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 KIRSCHNER WIRE W/ DRILL TIP/100MM. THIS IS REPORT 5 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491311 ↗
• 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 KIRSCHNER WIRE W/ DRILL TIP/100MM THIS IS REPORT 2 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491301 ↗
• MalfunctionSep 19, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A COMPLAINT WAS RECEIVED BY A SURGEON THAT THE KIRSCHNER WIRE W/DRILL TIP IN QUESTION WAS DULL AND NOT CUTTING INTO THE BONE AS DESIGNED. THERE WAS NO IMPACT TO THE PATIENT. THE SURGEON GOT THE ITEM INTO THE BONE EVENTUALLY AFTER IRRIGATING THE WIRE AND THE BONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM KIRSCHNER WIRE W/ DRILL TIP/100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447724 ↗

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