NA 03.010.495Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982069122), received between Feb 1, 2021 and Mar 5, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6), 2026 THAT THE INSIDE CANNULA WAS BENT. THERE WAS NO OPERATION INVOLVED AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524280 ↗
• MalfunctionJan 22, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING AN INTRA-OPERATIVE PROCEDURE, THE REDUCTION TOOL WAS SLIPPERY WHEN THE SURGEON ATTEMPTED TO USE IT. THE SURGEON DISCONTINUED USE OF THE TOOL AND SENT IT TO THE CENTRAL STERILE SUPPLY DEPARTMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY AND THERE WAS NO IMPACT OR CONSEQUENCE TO THE PATIENT. SUBSEQUENT REVIEW BY THE CSSD STAFF SUGGESTED THAT LUBRICANT FROM THE HEXAGONAL T-HANDLE CONNECTED TO THE REDUCTION TOOL MAY HAVE LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144179 ↗
• MalfunctionNov 11, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE DAY BEFORE THE SURGERY, THE OPERATING ROOM POINTED OUT THAT A TOTAL OF EIGHT ITEMS IN FIVE INSTRUMENT SETS HAD NOT BEEN PROPERLY CLEANED WHEN THEY DELIVERED. ALL THE IMPACTED PRODUCTS OF THE HOLLOW PARTS WERE DIRTY AND APPEARED TO BE BLOOD STAINS. WHEN A BRUSH WAS PASSED THROUGH THE HOLLOW PARTS IN THE OPERATING ROOM, THE BRUSH WAS FOUND TO BE DIRTY, AND SOME INSTRUMENTS WERE SO CLOGGED THAT A BRUSH COULD NOT BE PASSED THROUGH. THE SALES REP ORDERED NEW INSTRUMENTS, HOWEVER MANY OF THEM HAD DROPS OF WATER IN THE HOLLOW PART. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525814 ↗
• MalfunctionNov 11, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE DAY BEFORE THE SURGERY, THE OPERATING ROOM POINTED OUT THAT A TOTAL OF EIGHT ITEMS IN FIVE INSTRUMENT SETS HAD NOT BEEN PROPERLY CLEANED WHEN THEY DELIVERED. ALL THE IMPACTED PRODUCTS OF THE HOLLOW PARTS WERE DIRTY AND APPEARED TO BE BLOOD STAINS. WHEN A BRUSH WAS PASSED THROUGH THE HOLLOW PARTS IN THE OPERATING ROOM, THE BRUSH WAS FOUND TO BE DIRTY, AND SOME INSTRUMENTS WERE SO CLOGGED THAT A BRUSH COULD NOT BE PASSED THROUGH. THE SALES REP ORDERED NEW INSTRUMENTS, HOWEVER MANY OF THEM HAD DROPS OF WATER IN THE HOLLOW PART. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525811 ↗
• MalfunctionDec 5, 2023Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A REDUCTION TOOL WAS BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE IM REDUCTION TOOL/CURVED WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18265963 ↗
• MalfunctionMay 18, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE IM REDUCTION TOOL/CURVED WITH QUICK COUPLING WAS TWISTED, ONE DRILL BIT WAS WITHOUT EDGE AND ONE DRILL BIT WAS DAMAGED. THIS REPORT IS FOR ONE (1) IM REDUCTION TOOL/CURVED WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11843828 ↗
• MalfunctionMar 25, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE FLEXIBLE SHAFT BROKE, LARGE TOOL THREADS SNAPPED OFF AND THE REDUCTION TOOL FINGER BROKE. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1)IM REDUCTION TOOL/CURVED QUICK COUPLING. THIS REPORT IS 3 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11569830 ↗
• MalfunctionFeb 15, 2021Break; Break

  THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11329973 ↗
• MalfunctionFeb 1, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE TIP OF THE REDUCTION HEAD-ANGLED BROKE OFF. THE SOFT TISSUE BONE REDUCTION FORCEPS WITH BALL TIPS AND SOFT TISSUE ATTACHMENT J-SHAPE F/ REDUCTION FORCEPS BALL AND PLASTIC PIECE BROKE. THE REDUCTION TOOL/CURVED WITH QUICK COUPLING WOULDN'T ATTACH TO T HANDLE QUICK COUPLING (QC); IT SEEMED TO BE CROSS THREADED. TWO (2) 1.8MM COAXIAL DRILL GUIDES CROSS THREADED. TWO (2) RETRACTOR FOR SCIATIC NERVE WERE BENT. AND THE TIP OF THE REAMING ROD PUSH ROD BROKE OFF. ALL EQUIPMENT WAS USED DURING SURGERY AND HAD MALFUNCTIONED. SURGERY WAS DELAYED FIVE TO 10 (5-10) MINUTES. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR AN IM REDUCTION TOOL/CURVED WITH QUICK COUPLING. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11261889 ↗