NA 394.86Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982199911), received between Sep 18, 2018 and Oct 31, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

5 other recalls cover devices cleared under the same FDA submission (K033158, K082650, K122455, K950384); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Break; Crack; Break; Crack

  IT WAS REPORTED ON OCTOBER 8, 2025 THAT A LARGE EX FIX SET WAS INSPECTED AND IT WAS NOTICED MULTIPLE OF THE CARBON FIBER RODS OF SPLINTERED AND CRACKED. IT WAS NOT USED IN SURGERY OR HAD ANY ADVERSE EVENTS SO NO PATIENTS WERE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435786 ↗
• MalfunctionOct 31, 2025Break; Crack; Break; Crack

  IT WAS REPORTED ON OCTOBER 8, 2025 THAT A LARGE EX FIX SET WAS INSPECTED AND IT WAS NOTICED MULTIPLE OF THE CARBON FIBER RODS OF SPLINTERED AND CRACKED. IT WAS NOT USED IN SURGERY OR HAD ANY ADVERSE EVENTS SO NO PATIENTS WERE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435718 ↗
• MalfunctionOct 31, 2025Break; Crack; Break; Crack

  IT WAS REPORTED ON OCTOBER 8, 2025 THAT A LARGE EX FIX SET WAS INSPECTED AND IT WAS NOTICED MULTIPLE OF THE CARBON FIBER RODS OF SPLINTERED AND CRACKED. IT WAS NOT USED IN SURGERY OR HAD ANY ADVERSE EVENTS SO NO PATIENTS WERE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435575 ↗
• MalfunctionOct 31, 2025Break; Crack; Break; Crack

  IT WAS REPORTED ON (B)(6) 2025 THAT A LARGE EX FIX SET WAS INSPECTED AND IT WAS NOTICED MULTIPLE OF THE CARBON FIBER RODS OF SPLINTERED AND CRACKED. IT WAS NOT USED IN SURGERY OR HAD ANY ADVERSE EVENTS SO NO PATIENTS WERE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435249 ↗
• MalfunctionJul 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A LARGE EX FIX REVISION PROCEDURE ON (B)(6) 2024, THE STAFF COULD NOT GET THE CLAMP OFF THE 350MM CARBON FIBER ROD AND USED A NEW BAR AND CLAMP. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CASE DELAY. THIS REPORT IS FOR AN UNKNOWN LARGE EX-FIX CLAMP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19772040 ↗
• InjurySep 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE TIBIA ON (B)(6) 2018. THE INITIAL NONUNION WAS CAUSED BY THE SEVERITY OF INJURY AND COMMINUTION OF BONE FRAGMENTS. NO IMPLANTS USED IN FIRST STAGE FIXATION CAUSED NONUNION. FIRST STAGE FIXATION WAS PERFORMED WITH (9)SYNTHES LARGE EXTERNAL FIXATOR ON (B)(6) 2018. BONE GRAFT WAS HARVESTED ON (B)(6) 2018 USING THE RIA SYSTEM OF WHICH THE RIA DRIVE SHAFT IS A PART. THE CHOICE TO HARVEST BONE GRAFT FROM FEMUR TO APPLY IT TO TIBIA TO PROMOTE FRACTURE HEALING. NONE OF THE EXTERNAL FIXATOR PARTS FAILED. NO PARTS ARE AVAILABLE FOR RETURN. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS 8 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7887347 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033158, K082650, K122455, K950384. One submission often covers many models, so check the product and lot details in each record.

• Z-2451-2015 · Jul 29, 2015 · Terminated
  Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as th
• Z-1833-2014 · Apr 10, 2014 · Terminated
  Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
• Z-0941-2013 · Jan 11, 2013 · Terminated
  Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone
• Z-1816-2013 · Oct 12, 2012 · Open, Classified
  Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatme
• Z-0277-2013 · Sep 28, 2012 · Terminated
  Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation.