NA 394.85Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982199904), received between Apr 12, 2018 and Oct 31, 2025 — classified as 3 injuries, 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 23435413 ↗
• 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 23435306 ↗
• 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 23435168 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THE SURGEON DECIDED TO USE LARGE EXTERNAL FIXATOR CARBON BARS AND A COMBINATION CLAMP AS A STATIC KNEE SPACER INTERNALLY. HE PLANNED TO REMOVE THIS HARDWARE AND PERFORM A DISTAL FEMUR REPLACEMENT ONCE INFECTION SUBSIDED. NO COMPLAINTS OR ADVERSE EVENTS HAVE OCCURRED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE LRG EX-FIX 11 CRBN FBR ROD 300 / MR-COND. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15294463 ↗
• MalfunctionAug 14, 2019Break; Break

  09/12/2019: UPDATED. DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN EXTERNAL FIXATION SURGERY OF A DISTAL FEMUR FRACTURE, THE BLACK COATING OF THE CONNECTING CARBON FIBRE ROD OF THE LARGE EXTERNAL FIXATOR PEELED OFF AND ENDED UP IN THE PATIENT'S WOUND. AS A RESULT, THE IMPACT WAS THERE WAS A NEED FOR IRRIGATION OF THE WOUND TO REMOVE THE PARTICLES THAT CAME FROM THE ROD PRIOR TO CLOSURE WAS PERFORMED. ALL OF THE FRAGMENTS WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: LARGE COMBINATION CLAMP (PART: 390.005, LOT#: UNKNOWN, QUANTITY#: UNKNOWN), MULTI PIN CLAMP 4 POSITIONS (PART#: 390.004, LOT#: H028586 QUANTITY: 1), MULTI PIN CLAMP 6 POSITIONS (PART#: 390.002, LOT#: H805474 QUANTITY: 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8892908 ↗
• 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 AUGUST 20, 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 7 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7887342 ↗
• MalfunctionJul 19, 2018Crack; Mechanical Problem; Crack; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING A PELVIC SURGERY, THE EXTERNAL FIXATOR BAR WOULD NOT FIT INTO A CLAMP AS EXPECTED, AS THE END OF THE BAR WAS CRACKED. A DIFFERENT BAR WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE: EXTERNAL FIXATION CLAMP ¿ LARGE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A LARGE EXTERNAL FIXATOR 11MM CARBON FIBER ROD 300MM / MR-CONDITIONAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7703531 ↗
• InjuryApr 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN EX-FIX DEVICE EXPERIENCED A MAGNETIC PULL FROM BEING IN THE VICINITY OF MAGNETIC RESONANCE IMAGINING (MRI) AND THE SCAN WAS NOT PERFORMED AS A RESULT. THE PATIENT WAS NOT PUT INTO THE MACHINE. THIS WAS A POLY-TRAUMA (POST MOTORCYCLE ACCIDENT) PATIENT WHO WAS INTUBATED AND HAD A PELVIC EX-FIX IN PLACE SINCE A PROCEDURE ON (B)(6) 2018. HE WAS TO HAVE A C-SPINE (CERVICAL SPINE) MRI. THE PATIENT WAS OBSERVED TO BE KICKING HIS LEGS (HE WAS IN PAIN) IN RELATION TO BEING IN THE MRI AREA; BEING NEAR THE MACHINE WAS ENOUGH TO CAUSE A "PULL" ON HIS EX-FIX DEVICE. THE PLAN FOR THE MRI WAS ABORTED; NO MRI WAS DONE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR AN UNEVENTFUL PROCEDURE ON (B)(6) 2018 AT WHICH TIME THE EX-FIX WAS REMOVED. THIS COMPLAINT INVOLVES SEVEN DEVICES. THIS REPORT IS 4 OF 7 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7427525 ↗

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.