ILIZAROV SYSTEMS 71070341Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 08033201842072), received between Mar 7, 2019 and Mar 4, 2022 — classified as 5 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K093047); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2022Break; Mechanics Altered; Break; Mechanics Altered

  IT WAS REPORTED THAT, DURING SURGERY, A WIRE TENSIONER DID NOT TENSION AND BROKE OUTSIDE OF 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 13671466 ↗
• InjuryMar 4, 2022Break; Mechanics Altered; Break; Mechanics Altered

  IT WAS REPORTED THAT, DURING SURGERY A WIRE TENSIONER DID NOT TENSION AND BROKE OUTSIDE OF 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 13671298 ↗
• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING A EXTERNAL FIXATION SURGERY AN WIRE TENSIONER WAS BROKEN. NO PIECES FELL INTO PATIENT. SURGERY WAS FINISHED WITH A S&N BACKUP DEVICE, WITHOUT ANY SURGICAL DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12763238 ↗
• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING A FRAME SURGERY, A WIRE TENSIONER BROKE. NO PIECES FELL INTO PATIENT. SURGERY 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 12759781 ↗
• MalfunctionOct 29, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION SURGERY, THE TIP OF A WIRE TENSIONER BROKE OFF. INCIDENT OCCURRED WITH INSTRUMENTS OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITH A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12722664 ↗
• MalfunctionSep 24, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, ONE WIRE TENSIONER BROKE OFF. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12524142 ↗
• MalfunctionJun 22, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT A WIRE TENSIONER SPRING DOES NOT HOLD TENSION. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042986 ↗
• MalfunctionJun 15, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, A WIRE TENSIONER HOLDS A WIRE AND CAN'T REMOVE IT. IT IS UNKNOWN IF THE EVENT HAPPENED DURING SURGERY OR IF THERE WAS ANY DELAY NOR INJURY REPORTED. IT IS UNKNOWN IF THERE WAS A S&N BACKUP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12001972 ↗
• MalfunctionMay 7, 2021Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SURGERY A WIRE WAS STUCK IN ONE WIRE TENSIONER (CASE: (B)(4)). ADDITIONALLY, ANOTHER WIRE TENSIONER WAS NOT GRIPPING (CASE: (B)(4)). NO DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794876 ↗
• MalfunctionMay 7, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING SURGERY A WIRE WAS STUCK IN ONE WIRE TENSIONER (CASE: (B)(4)). ADDITIONALLY, ANOTHER WIRE TENSIONER WAS NOT GRIPPING (CASE: (B)(4)). NO DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794814 ↗
• MalfunctionApr 15, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING SET UP INSPECTION PROCESS, PRIOR TO SURGERY, IT WAS NOTICED THAT THE WIRE TENSIONER DID NOT LONGER GRIP WIRES. THE PROCEDURE WAS COMPLETED 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 11671485 ↗
• MalfunctionApr 6, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE TENSIONER WOULD NOT HOLD THE WIRE. THIS FAILURE WAS NOTICED DURING USE, WHILE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624904 ↗
• MalfunctionApr 6, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, TENSIONER DOES NOT HOLD TENSION WHEN TESTED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617562 ↗
• MalfunctionApr 6, 2021Corroded; Corroded

  IT WAS REPORTED THAT SPD STAFF FOUND RUST IN THE WIRE TENSIONER. NO CASE OR PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617541 ↗
• MalfunctionMar 1, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING SURGERY THE WIRE TENSIONER FAILED TO TIGHTEN. SURGERY BEING DONE WAS A DEFORMITY. INSTRUMENTS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391109 ↗
• MalfunctionFeb 11, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE TENSIONER IS VERY OLD AND WILL NOT NOW HOLD THE WIRE. EVENT OCCURRED DURING USE. PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11312294 ↗
• MalfunctionFeb 10, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO INSERT A WIRE TENSIONER TO TEST FUNCTIONALITY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11311736 ↗
• MalfunctionJan 13, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TSF CASE, IT WAS NOTICED THAT THE WIRE TENSIONER WAS NOT WORKING AND WOULD NOT TENSION WIRES. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH AN SMITH & NEPHEW BACKUP DEVICE. NO PATIENT HARM OR ADDITIONAL COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11158279 ↗
• MalfunctionJan 7, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE WIRE TENSIONER PRESENTED DIFFICULTIES FOR GAINING ADEQUATE TENSION. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING A BACKUP FROM SMITH & NEPHEW. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED AT THE MOMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11133896 ↗
• MalfunctionJan 6, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE SET UP OF AN UNKNOWN PROCEDURE THE WIRE TENSIONER WAS NOT TENSIONING. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11124378 ↗
• MalfunctionJan 4, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE SET UP OF AN UNKNOWN PROCEDURE THE WIRE TENSIONER WAS NOT TENSIONING. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11113830 ↗
• InjuryDec 9, 2020Connection Problem; Mechanical Jam; Connection Problem; Mechanical Jam

  IT WAS REPORTED THAT, THE JAWS OF A WIRE TENSIONER COULD NOT GO ONTO THE WIDE, AND THE TENSIONER COULD NOT BE REMOVED FROM THE WIRE; THEREFORE, THE WIRE HAD TO BE CUT. INCIDENT OCCURRED DURING A ILLIZAROV FRAME CASE WITH INSTRUMENTS INSIDE THE PATIENT, THE SURGEON WAS NOT ABLE TO PROCEED WITH THE CASE AS THE TENSIONER WAS DEFUNCT. THERE WAS A DELAY GREATER THAN 30 MIN. IT WAS ALSO REPORTED A POTENTIAL FRAME INSTABILITY AND A HIGHER RISK OF INFECTION. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10980067 ↗
• MalfunctionDec 9, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING USE, INSTRUMENT OUTSIDE THE PATIENT, THE HANDLE OF THE DEVICE WAS DIFFICULT TO MOVE. IT COULD NOT TENSION AS INTENDED. WITH A SMITH + NEPHEW BACK UP DEVICE, THE SURGERY FINISHED. NO PROCEDURAL DELAY. NO SERIOUS INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10980012 ↗
• MalfunctionNov 11, 2020Defective Device; Mechanical Jam; Defective Device; Mechanical Jam

  IT WAS REPORTED THAT, DURING SURGERY, THE WIRE TENSIONER WON'T TENSION. THE PROCEDURE WAS COMPLETED WITH A S+N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10825307 ↗
• MalfunctionOct 6, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED FROM THE LOANERS DEPARTMENT THAT THE INSTRUMENT DOES NOT RETAINS TENSION. IT IS UNKNOWN WHEN THE EVENT OCCURRED. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10637183 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093047. One submission often covers many models, so check the product and lot details in each record.

• Z-0245-2022 · Jun 17, 2021 · Open, Classified
  Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434