NA 390.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982197856), received between Feb 13, 2018 and Nov 4, 2025 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 reports).

5 other recalls cover devices cleared under the same FDA submission (K031428, K033158, K082650, K122455); 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE SPRING ON THE DEVICE IS STIFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468432 ↗
• MalfunctionApr 2, 2024Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON MARCH 17, 2024, THE SCREW WAS LOOSE. THE CONNECTING PART DOES NOT ROTATE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19021588 ↗
• MalfunctionMar 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS FOUND THAT THE SCREW PART OF THE DEVICE DOES NOT MOVE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521398 ↗
• MalfunctionApr 12, 2022Connection Problem; Connection Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS DETERMINED ON AN UNKNOWN DATE FIVE (5) EX-FIX CLAMPS WERE UNABLE TO CONNECT. IT WAS STATED THE ROD DOES NOT FIT WELL. PATIENT AND SURGICAL INVOLVEMENT IS UNKNOWN. NO SERIOUS INJURY REPORTED. THIS IS REPORT 5 OF 5 FOR (B)(4). THIS REPORT IS FOR A LARGE EX-FIX CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083431 ↗
• MalfunctionApr 12, 2022Connection Problem; Connection Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS DETERMINED ON AN UNKNOWN DATE FIVE (5) EX-FIX CLAMPS WERE UNABLE TO CONNECT. IT WAS STATED THE ROD DOES NOT FIT WELL. PATIENT AND SURGICAL INVOLVEMENT IS UNKNOWN. NO SERIOUS INJURY REPORTED. THIS IS REPORT 4 OF 5 FOR (B)(4). THIS REPORT IS FOR A LARGE EX-FIX CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083417 ↗
• MalfunctionApr 12, 2022Connection Problem; Connection Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS DETERMINED ON AN UNKNOWN DATE FIVE EX-FIX CLAMPS WERE UNABLE TO CONNECT. IT WAS STATED THE ROD DOES NOT FIT WELL. PATIENT AND SURGICAL INVOLVEMENT IS UNKNOWN. NO SERIOUS INJURY REPORTED. THIS IS REPORT 3 OF 5 FOR (B)(4). THIS REPORT IS FOR A LARGE EX-FIX CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083389 ↗
• MalfunctionApr 12, 2022Connection Problem; Connection Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS DETERMINED ON AN UNKNOWN DATE FIVE EX-FIX CLAMPS WERE UNABLE TO CONNECT. IT WAS STATED THE ROD DOES NOT FIT WELL. PATIENT AND SURGICAL INVOLVEMENT IS UNKNOWN. NO SERIOUS INJURY REPORTED. THIS IS REPORT 2 OF 5 FOR (B)(4). THIS REPORT IS FOR A LARGE EX-FIX CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083370 ↗
• MalfunctionApr 12, 2022Connection Problem; Connection Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS DETERMINED ON AN UNKNOWN DATE FIVE (5) EX-FIX CLAMPS WERE UNABLE TO CONNECT. IT WAS STATED THE ROD DOES NOT FIT WELL. PATIENT AND SURGICAL INVOLVEMENT IS UNKNOWN. NO SERIOUS INJURY REPORTED. THIS IS REPORT 1 OF 5 FOR (B)(4). THIS REPORT IS FOR A LARGE EX-FIX CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083358 ↗
• MalfunctionFeb 10, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A PROCEDURE ON (B)(6) 2022, THE CLIP ON THE SELF-HOLDING MECHANISM OF THE CLAMP DID NOT WORK PROPERLY; IT WAS LOOSE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509428 ↗
• InjurySep 14, 2020Break; Break

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHILE THUMB TIGHTENING THE EX-FIX OPEN ADJUSTING CLAMP, A METAL SHARD BROKE OFF FROM THE THUMB WHEEL AND CAUSED A SHARPS INJURY TO THE SURGEON. FRAGMENTS WERE GENERATED AND SUCCESSFULLY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS AN UNKNOWN AMOUNT OF SURGICAL DELAY.

  Patient problems: No Code Available

  MAUDE report 10528208 ↗
• MalfunctionAug 20, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT THE LARGE OPEN ADJUSTABLE CLAMP WAS UNABLE TO CLAMP FIRMLY. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10431069 ↗
• 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 5 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8740146 ↗
• 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 4 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8740074 ↗
• 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 3 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8739790 ↗
• MalfunctionJun 26, 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 1 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8736479 ↗
• MalfunctionApr 10, 2019Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, THE SCREW OF THE SELF-HOLDING CLAMP WAS LOOSEN AND THE NUT WAS UNMOVABLE. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8500791 ↗
• MalfunctionJul 30, 2018Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, TWO CLAMPS EXPERIENCED A HOLDING FAILURE. THERE WAS NO PATIENT INVOLVED. THIS REPORT IS FOR A LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL. (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7731277 ↗
• MalfunctionJul 30, 2018Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, TWO CLAMPS EXPERIENCED A HOLDING FAILURE. THERE WAS NO PATIENT INVOLVED. THIS REPORT IS FOR A LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL. (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7731248 ↗
• 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 7 OF 7 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7427542 ↗
• 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 3 OF 7 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7427484 ↗
• MalfunctionFeb 13, 2018Device Operates Differently Than Expected; Unintended Movement; Device Operates Differently Than Expected; Unintended Movement

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE LARGE OPEN PEN ADJ-CLAMO MR-CONDITIONAL WAS UNABLE TO HOLD ON FIRMLY. THIS IS ALL INFORMATION THAT HAVE BEEN OBTAINED. COMPLAINT INVOLVES ONE PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7266730 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031428, K033158, K082650, K122455. 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.