NA 03.311.032Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982077974), received between Jul 16, 2019 and Dec 12, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K051600, K092190, K161417); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, A TENSIONER HAD AN UNKNOWN ALLEGATION. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THE PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR 1 SMOOTH WIRE/1.8MM DIAMETER 400MM LONG THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10994640 ↗
• MalfunctionOct 25, 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 9238160 ↗
• InjuryJul 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A MAXFRAME ADJUSTMENT. THE SURGEON WANTED TO ADD A FOOT SUPPORT KIT AND CHANGE A WIRE. IT WAS NOTED THAT THE SKIN INCISION WAS NOT RELAXED ENOUGH INITIALLY ALONG WITH INITIAL SWELLING MAY HAVE CAUSED REDNESS DUE TO TENTING OF SKIN. THAT IS WHY THE SMOOTH WIRE WAS REMOVED AND PLACED IT WITH NEW REDUCTION WIRE. WIRE WAS INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Swelling

  MAUDE report 8793479 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051600, K092190, K161417. One submission often covers many models, so check the product and lot details in each record.

• Z-1833-2014 · Apr 10, 2014 · Terminated
  Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
• Z-1324-2009 · Feb 9, 2009 · Terminated
  Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in conjunction with Synthes Distraction Osteogenesis Ring Systems. It can be used to secure componen