ILIZAROV SYSTEMS 102911Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010031839), received between Feb 5, 2019 and Jul 18, 2022 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2022Crack; Crack

  IT WAS REPORTED THAT, DURING SURGERY, THE SIDE PART OF SPANNER OF THE FIXATION BOLT WRENCH CRACKED AND COME AWAY FROM MAIN BODY WHILST TIGHTENING A BOLT. DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15038800 ↗
• MalfunctionMar 31, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE FIXATION BOLT WRENCH BROKE, OUTSIDE OF THE PATIENT. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13961431 ↗
• MalfunctionOct 29, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION SURGERY, A FIXATION BOLT WRENCH BROKE OFF. NO SURGICAL DELAY WAS REPORTED TO OCCUR DUE TO THIS INCIDENT, AS A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE TO CONCLUDE THE PROCEDURE. NO PATIENT HARM WAS REPORTED TO OCCUR DUE TO THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719633 ↗
• MalfunctionSep 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION PROCEDURE, A FIXATION BOLT WRENCH BROKE WHILE TIGHTENING, INSTRUMENT WERE OUTSIDE THE PATIENT. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12539785 ↗
• MalfunctionAug 5, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION ONE SIDE OF A FIXATION BOLT WRENCH WERE SHEARED OFF DURING THE TIGHTENING OF A NUT. SURGERY WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE, WITHOUT ANY SURGICAL DELAY. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285685 ↗
• MalfunctionApr 11, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE FIXATION BOLT WRENCH BROKE WHILE USING IT OUTSIDE THE PATIENT. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646834 ↗
• InjuryMar 23, 2021Break; Break

  IT WAS REPORTED THAT, DURING PROCEDURE WHEN TIGHTENING FIXATION BOLT WRENCH, THIS BROKE. INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548663 ↗
• MalfunctionFeb 21, 2021Break; Break

  IT WAS REPORTED THAT THE FIXATION BOLT WRENCH IS BROKEN. UNKNOWN WHEN THIS EVENT HAPPENED AND IF THERE IS A PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356760 ↗
• MalfunctionJan 18, 2021Break; Break

  IT WAS REPORTED THAT, THE END BIT OF THE WRENCH BROKE OFF DURING USE OUTSIDE OF THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11189774 ↗
• MalfunctionJul 24, 2019Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, SURGEON WAS TIGHTENING COMBI BOLT AND ONE SIDE OF THE WRENCH TEETH BROKE OFF. NO MORE INFORMATION PROVIDED YET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824199 ↗
• MalfunctionMay 26, 2019Break; Break

  IT WAS REPORTED THAT DURING A SURGERY, WIRE FIXATION WRENCH EDGES HAVE STARTED TO BREAK AWAY ABOVE THE INCISION. NO PIECES FELL INTO THE WOUND AND NO INJURY. THERE WAS NO DELAY. PROCEDURE WAS CONCLUDED WITH A BACKUP DEVICE FROM SMITH AND NEPHEW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8643147 ↗
• MalfunctionFeb 5, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, FRAGMENT OF THE 90-DEGREE WRENCH BROKE OFF WHEN TIGHTENING A BOLT DURING NORMAL USE. NO DELAY OR INJURY REPORTED. A BACKUP DEVICE WAS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8307908 ↗