NA 03.311.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982077769), received between Oct 7, 2019 and Feb 12, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON NOVEMBER 16, 2020, THE PATIENT UNDERWENT A DO RING FIXATOR APPLICATION FOR SHARCOTS FOOT (R), DISTAL TIBIA PROCEDURE. DURING TENSIONING OF THE SMOOTH WIRE THE TENSIONER CAME APART RESULTING IN THE SMOOTH WIRE BEING STUCK IN THE TENSIONER. THE WIRE HAD TO BE CUT IN ORDER TO REMOVE THE TENSIONING DEVICE. A BACK-UP TENSIONER WAS USED AND THE SURGERY CONTINUED. THERE WAS AN APPROXIMATELY FIVE (5) MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT REPORTEDLY HAD NO ISSUES. DURING THE INVESTIGATION OF THE RETURNED DEVICE IT WAS NOTED THAT DEVICE DID NOT TENSION CORRECTLY. THIS REPORT IS FOR A TENSIONER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11320911 ↗
• MalfunctionDec 26, 2019Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A WIRE TIGHTENER WAS NOT FUNCTIONING PROPERLY AND IT LOOKED LIKE THAT AN UNKNOWN WIRE WAS STUCK INSIDE. PROCEDURE AND PATIENT INVOLVEMENT ARE STILL UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) TENSIONER. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9520713 ↗
• MalfunctionOct 24, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A FOOT SURGERY, THE TWO (2) TENSIONERS WOULD NOT RELEASE REDUCTION WIRE DURING THE APPLICATION OF A DISTRACTION OSTEOGENESIS (DO) RING FIXATOR FRAME. IT CAME APART DURING THE ATTEMPTS TO RELEASE THE WIRE FROM THE TENSIONER INTRAOPERATIVELY. THERE ARE TWO TENSIONERS THAT FAILED DURING THE PROCEDURE. ANOTHER ONE (1) TENSIONER COMES TO A HARD STOP WHEN COMPLETELY RELEASING TENSION. IT IS SUPPOSED TO CLICK AND CONTINUE TO ROTATE WHEN ALL TENSION HAS BEEN RELEASED REACHING ITS ENDPOINT HOWEVER, IT DID NOT ¿CLICK¿ WHEN THE HANDLE WAS FULLY OPENED. THE SAME TYPE OF TENSIONER WAS USED TO COMPLETE THE PROCEDURE. NO ISSUE WITH WIRE. TENSIONER¿S FAILED ON BOTH REDUCTION WIRES AND SMOOTH WIRES. RIGHT LOWER EXTREMITY MULTIPLANAR RING EXTERNAL FIXATOR. WIRE DID NOT APPEAR TO BE THE ISSUE. TENSIONER MALFUNCTION OCCURRED ON SEVERAL DIFFERENT WIRES. TWO OF THE TENSIONERS TERMINALLY IMPINGED ON THE WIRE. IN AN EFFORT TO RELEASE THE TENSIONER FROM THE WIRE THE PHYSICIAN CONTINUED TO TURN THE HANDLE COUNTER CLOCKWISE. TWO OF THE TENSIONERS BECAME DISASSEMBLED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235287 ↗
• MalfunctionOct 24, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A FOOT SURGERY, THE TWO (2) TENSIONERS WOULD NOT RELEASE REDUCTION WIRE DURING THE APPLICATION OF A DISTRACTION OSTEOGENESIS (DO) RING FIXATOR FRAME. IT CAME APART DURING THE ATTEMPTS TO RELEASE THE WIRE FROM THE TENSIONER INTRAOPERATIVELY. THERE ARE TWO TENSIONERS THAT FAILED DURING THE PROCEDURE. ANOTHER ONE (1) TENSIONER COMES TO A HARD STOP WHEN COMPLETELY RELEASING TENSION. IT IS SUPPOSED TO CLICK AND CONTINUE TO ROTATE WHEN ALL TENSION HAS BEEN RELEASED REACHING ITS ENDPOINT HOWEVER, IT DID NOT ¿CLICK¿ WHEN THE HANDLE WAS FULLY OPENED. THE SAME TYPE OF TENSIONER WAS USED TO COMPLETE THE PROCEDURE. NO ISSUE WITH WIRE. TENSIONER¿S FAILED ON BOTH REDUCTION WIRES AND SMOOTH WIRES. RIGHT LOWER EXTREMITY MULTIPLANAR RING EXTERNAL FIXATOR. WIRE DID NOT APPEAR TO BE THE ISSUE. TENSIONER MALFUNCTION OCCURRED ON SEVERAL DIFFERENT WIRES. TWO OF THE TENSIONERS TERMINALLY IMPINGED ON THE WIRE. IN AN EFFORT TO RELEASE THE TENSIONER FROM THE WIRE THE PHYSICIAN CONTINUED TO TURN THE HANDLE COUNTER CLOCKWISE. TWO OF THE TENSIONERS BECAME DISASSEMBLED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235278 ↗
• MalfunctionOct 24, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A FOOT SURGERY, THE TWO (2) TENSIONERS WOULD NOT RELEASE REDUCTION WIRE DURING THE APPLICATION OF A DISTRACTION OSTEOGENESIS (DO) RING FIXATOR FRAME. IT CAME APART DURING THE ATTEMPTS TO RELEASE THE WIRE FROM THE TENSIONER INTRAOPERATIVELY. THERE ARE TWO TENSIONERS THAT FAILED DURING THE PROCEDURE. ANOTHER ONE (1) TENSIONER COMES TO A HARD STOP WHEN COMPLETELY RELEASING TENSION. IT IS SUPPOSED TO CLICK AND CONTINUE TO ROTATE WHEN ALL TENSION HAS BEEN RELEASED REACHING ITS ENDPOINT HOWEVER, IT DID NOT ¿CLICK¿ WHEN THE HANDLE WAS FULLY OPENED. THE SAME TYPE OF TENSIONER WAS USED TO COMPLETE THE PROCEDURE. NO ISSUE WITH WIRE. TENSIONER¿S FAILED ON BOTH REDUCTION WIRES AND SMOOTH WIRES. RIGHT LOWER EXTREMITY MULTIPLANAR RING EXTERNAL FIXATOR. WIRE DID NOT APPEAR TO BE THE ISSUE. TENSIONER MALFUNCTION OCCURRED ON SEVERAL DIFFERENT WIRES. TWO OF THE TENSIONERS TERMINALLY IMPINGED ON THE WIRE. IN AN EFFORT TO RELEASE THE TENSIONER FROM THE WIRE THE PHYSICIAN CONTINUED TO TURN THE HANDLE COUNTER CLOCKWISE. TWO OF THE TENSIONERS BECAME DISASSEMBLED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235267 ↗
• MalfunctionOct 7, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN ORTHOPEDIC PROCEDURE, THE TENSIONER WOULD NOT RELEASE AN UNKNOWN WIRE AND ENDED UP BROKEN. THE SURGEON HAD TO MANUALLY TWIST IT OFF AND USED THE BACKUP TENSIONER. THERE WERE NO FRAGMENTS GENERATED. THE BROKEN DEVICE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NOT AFFECTED AND THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) TENSIONER. THIS IS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9164277 ↗