NA 03.111.023Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982072221), received between Aug 14, 2019 and Jun 17, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (5 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE INSTRUMENTS WERE DULL AND NEED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236109 ↗
• MalfunctionJun 17, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT INSTRUMENTS WERE DULL AND NEED REPLACEMENT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235520 ↗
• MalfunctionJun 17, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT INSTRUMENTS WERE DULL AND NEED REPLACEMENT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235495 ↗
• MalfunctionJun 17, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT INSTRUMENTS WERE DULL AND NEED REPLACEMENT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235404 ↗
• MalfunctionJun 17, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT INSTRUMENTS WERE DULL AND NEED REPLACEMENT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235241 ↗
• MalfunctionJun 28, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE COMPRESSION DISTRACTION PIN HOLDERS ARE BENT. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS NOTED THAT THE DEVICE WAS BENT. ADDITIONALLY, A K-WIRE WAS UNABLE TO DETACH FROM THE DEVICE. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION HOLDING SLEEVE/2.5MM K-WIRE THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19637266 ↗
• MalfunctionMar 9, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE COMPRESSION SLEEVE WAS UNABLE TO CONNECT. UNREPAIRABLE LETTER WAS ISSUED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION HOLDING SLEEVE/2.5MM K-WIRE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513672 ↗
• MalfunctionFeb 25, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021 THAT THE SLEEVE WAS BENT. IT WAS UNKNOWN WHEN AND HOW THE INCIDENT HAPPENED. IT WAS UNKNOWN IF THERE ANY PROCEDURE AND PATIENT INVOLVED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) COMPRESSION/DISTRACTION HOLDING SLEEVE/2.5MM K-WIRE. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382204 ↗
• MalfunctionAug 14, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2019, DURING AN INVENTORY OF THE FOOT INSTRUMENT SET, IT WAS NOTICED THAT ONE OF THE COMPRESSION OR DISTRACTION HOLDING SLEEVES, THE THREAD ARE STRIPPING AND IS NOT WORKING CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION HOLDING SLEEVE/2.5 MM K-WIRE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8893087 ↗