ILIZAROV SYSTEMSRecalls & reported problems across all models

We found 3 models of ILIZAROV SYSTEMS by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Feb 5, 2019 and Jul 18, 2022 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ILIZAROV SYSTEMS problems

ILIZAROV SYSTEMS models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ILIZAROV SYSTEMS 102911

  WRENCH
  12 reports
• ILIZAROV SYSTEMS 71070367

  APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
  11 reports
• ILIZAROV SYSTEMS 103000

  WRENCH
  1 report

Recent ILIZAROV SYSTEMS adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJun 22, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN EXTERNAL FIXATION, A RATCHET WRENCH HAD FAILED TO FUNCTION PROPERLY BECAUSE IT SIZED UP. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038904 ↗
• MalfunctionMay 26, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN EXTERNAL FIXATION SURGERY, THE HANDLE OF A RATCHET WRENCH WAS JAMMING. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887428 ↗
• MalfunctionMay 11, 2021Corroded; Corroded

  IT WAS REPORTED THAT, A RATCHET WRENCH WAS SEEN TO STICK, A UNIVERSAL CHUCK DID NOT TIGHTEN PROPERLY, A TUBULAR ANGULATED WRENCH WAS RUSTY, A DRILL TISSUE PROTECTOR - LONG AND A DEPTH GAUGE SHORT WERE BENT. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806441 ↗
• MalfunctionMay 11, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, A RATCHET WRENCH WAS SEEN TO STICK, A UNIVERSAL CHUCK DID NOT TIGHTEN PROPERLY, A TUBULAR ANGULATED WRENCH WAS RUSTY, A DRILL TISSUE PROTECTOR - LONG AND A DEPTH GAUGE SHORT WERE BENT. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806390 ↗
• MalfunctionMay 5, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, THE GREY/GOLD DRIVER OF A RATCHET WRENCH WAS FROZEN. AS THIS WAS NOTICED AFTER A TRAUMA SURGERY DURING A POST-OPERATIVE INSPECTION OF INSTRUMENTS IN THE STERILE PROCESSING DEPARTMENT., NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781358 ↗
• 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 ↗
• MalfunctionMar 29, 2021Break; Break

  IT WAS REPORTED THAT THE DEPTH GAUGE SHORT IS BROKEN AND THE RATCHET WRENCH IS BROKEN AND STRIPPED. UNKNOWN WHEN THIS HAPPENED OR IF THERE IS A PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586742 ↗
• 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 ↗

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