NA 390.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982197825), received between Apr 12, 2018 and Aug 25, 2026 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (15 reports).

5 other recalls cover devices cleared under the same FDA submission (K030390, K033158, K082650, K122455, 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Device-Device Incompatibility; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50429924 ↗
• MalfunctionAug 25, 2026Device-Device Incompatibility; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50429923 ↗
• MalfunctionMar 13, 2026Device Slipped

  IT WAS REPORTED THAT THE SCREW PART OF THE CLAMP HAS BECOME STUCK, AND CAN NO LONGER BE TIGHTENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597496 ↗
• MalfunctionFeb 5, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT THE COMBO CLAMP WAS JAMMED/BROKEN DURING AN EX FIX. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272499 ↗
• MalfunctionSep 29, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, NUT ON EXFIX COMBI CLAMP WAS TOO TIGHT AS TO ADJUST BY HAND. THIS WAS AN EX FIX OF ANKLE (NOT PELVIS). THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) LRG EX-FIX COMBINATION CLAMP MR-COND. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843003 ↗
• MalfunctionMar 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, A SALES REP NOTIFIED A LARGE CLAMP WAS STUCK TOGETHER WHEN OPENED OUT OF THE PACKAGING. THE CLAMP WAS IMPLANTED BUT COULD NOT HAND TIGHTEN. IT¿S WEDGE IS SUPER TIGHT AND HAVE TO TIGHTEN IT WITH T-HANDLE CHUCK BEFORE THE ACTUAL CASE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521868 ↗
• MalfunctionDec 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2022 THE BALL JOINT WAS NOT WORKING. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968651 ↗
• MalfunctionDec 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, 11 TOTAL BAR TO BAR AND PIN TO BAR CLAMPS COLD WELDED. THE SURGEON SPENT AN EXTRA 30 MINUTES DURING THE CASE ON BILATERAL EX-FIXES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL. THIS IS REPORT 11 OF 11 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968345 ↗
• MalfunctionDec 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, 11 TOTAL BAR TO BAR AND PIN TO BAR CLAMPS COLD WELDED. THE SURGEON SPENT AN EXTRA 30 MINUTES DURING THE CASE ON BILATERAL EX-FIXES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL. THIS IS REPORT 10 OF 11 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968344 ↗
• MalfunctionDec 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, 11 TOTAL BAR TO BAR AND PIN TO BAR CLAMPS COLD WELDED. THE SURGEON SPENT AN EXTRA 30 MINUTES DURING THE CASE ON BILATERAL EX-FIXES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL. THIS IS REPORT 9 OF 11 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968342 ↗
• MalfunctionDec 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, 11 TOTAL BAR TO BAR AND PIN TO BAR CLAMPS COLD WELDED. THE SURGEON SPENT AN EXTRA 30 MINUTES DURING THE CASE ON BILATERAL EX-FIXES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL. THIS IS REPORT 7 OF 11 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968339 ↗
• MalfunctionDec 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, 11 TOTAL BAR TO BAR AND PIN TO BAR CLAMPS COLD WELDED. THE SURGEON SPENT AN EXTRA 30 MINUTES DURING THE CASE ON BILATERAL EX-FIXES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL. THIS IS REPORT 8 OF 11 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968338 ↗
• MalfunctionSep 29, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON EXPRESSED THAT THE LARGE COMBINATION EX FIX CLAMPS DID NOT GRAB ON TO THE 4.0 EX FIX SCHANZ SCREWS AS WELL AS THE MEDIUM COMBINATION CLAMPS. THE SURGEON DECIDED TO USE THE 8.0/11MM COMBINATION CLAMPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) LRG EX-FIX COMBINATION CLAMP MR-COND THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503119 ↗
• 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 (1) LRG EX-FIX COMBINATION CLAMP MR-COND. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15294426 ↗
• MalfunctionNov 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, DURING A PROCEDURE, AS THE SURGEON WAS APPLYING AN EXTERNAL FIXATION FRAME, A CLAMP THAT HAD CLEARLY BEEN REPROCESSED BY MEDLINE, WAS FOUND TO BE MALFUNCTIONING AND WOULDN'T TIGHTEN. IT WAS SET ASIDE FOR A FORMAL COMPLAINT AND NOT USED. THE CLAMP WAS SET ASIDE FOR FURTHER EXAMINATION. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) LRG EX-FIX COMBINATION CLAMP MR-COND. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821211 ↗
• MalfunctionJun 27, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN EXTRA-WOUND ANCHORAGE WAS APPLIED FOR FOOT JOINT SURGERY. DURING THE SURGERY, THE SURGEON USED FOUR (4) LARGE OPEN ADJUSTABLE CLAMP AND FOUR (4) LARGE COMBINATION CLAMP WERE BOTH IN QUESTION IN ACCORDANCE WITH THE SURGICAL TECHNIQUE. THE CLIP PARTS OF ALL CLAMPS DID NOT HOLD OTHER INSTRUMENTS WELL WHILE THE NUTS OF THE CLAMPS WERE FULLY UNTIGHTENED. THE SURGEON STATED THAT HE COULD NOT CONNECT THE INSTRUMENTS SMOOTHLY. THE FIXATION WAS SUCCESSFULLY OBTAINED USING THE REPORTED DEVICES AND THE SURGERY WAS COMPLETED WITHOUT OTHER PROBLEM. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT STATUS WAS STABLE. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8740247 ↗
• MalfunctionJun 27, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN EXTRA-WOUND ANCHORAGE WAS APPLIED FOR FOOT JOINT SURGERY. DURING THE SURGERY, THE SURGEON USED FOUR (4) LARGE OPEN ADJUSTABLE CLAMP AND FOUR (4) LARGE COMBINATION CLAMP WERE BOTH IN QUESTION IN ACCORDANCE WITH THE SURGICAL TECHNIQUE. THE CLIP PARTS OF ALL CLAMPS DID NOT HOLD OTHER INSTRUMENTS WELL WHILE THE NUTS OF THE CLAMPS WERE FULLY UNTIGHTENED. THE SURGEON STATED THAT HE COULD NOT CONNECT THE INSTRUMENTS SMOOTHLY. THE FIXATION WAS SUCCESSFULLY OBTAINED USING THE REPORTED DEVICES AND THE SURGERY WAS COMPLETED WITHOUT OTHER PROBLEM. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT STATUS WAS STABLE. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8740220 ↗
• MalfunctionJun 27, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN EXTRA-WOUND ANCHORAGE WAS APPLIED FOR FOOT JOINT SURGERY. DURING THE SURGERY, THE SURGEON USED FOUR (4) LARGE OPEN ADJUSTABLE CLAMP AND FOUR (4) LARGE COMBINATION CLAMP WERE BOTH IN QUESTION IN ACCORDANCE WITH THE SURGICAL TECHNIQUE. THE CLIP PARTS OF ALL CLAMPS DID NOT HOLD OTHER INSTRUMENTS WELL WHILE THE NUTS OF THE CLAMPS WERE FULLY UNTIGHTENED. THE SURGEON STATED THAT HE COULD NOT CONNECT THE INSTRUMENTS SMOOTHLY. THE FIXATION WAS SUCCESSFULLY OBTAINED USING THE REPORTED DEVICES AND THE SURGERY WAS COMPLETED WITHOUT OTHER PROBLEM. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT STATUS WAS STABLE. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8740202 ↗
• MalfunctionJun 27, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN EXTRA-WOUND ANCHORAGE WAS APPLIED FOR FOOT JOINT SURGERY. DURING THE SURGERY, THE SURGEON USED FOUR (4) LARGE OPEN ADJUSTABLE CLAMP AND FOUR (4) LARGE COMBINATION CLAMP WERE BOTH IN QUESTION IN ACCORDANCE WITH THE SURGICAL TECHNIQUE. THE CLIP PARTS OF ALL CLAMPS DID NOT HOLD OTHER INSTRUMENTS WELL WHILE THE NUTS OF THE CLAMPS WERE FULLY UNTIGHTENED. THE SURGEON STATED THAT HE COULD NOT CONNECT THE INSTRUMENTS SMOOTHLY. THE FIXATION WAS SUCCESSFULLY OBTAINED USING THE REPORTED DEVICES AND THE SURGERY WAS COMPLETED WITHOUT OTHER PROBLEM. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT STATUS WAS STABLE. THIS IS REPORT 2 OF 8 FOR (B)(4)..

  Patient problems: No Patient Involvement

  MAUDE report 8739754 ↗
• 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 5 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7887331 ↗
• 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 2 OF 7 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7427483 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030390, K033158, K082650, K122455, K161417. 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.