NA 294.786Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982182197), received between Apr 12, 2018 and Sep 9, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K082650, K122455, K161417, K952296); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE PUTTING ON A SYNTHES LG EXTERNAL FIXATOR. THE SURGEON WAS USING A SELF DRILLING SCHANZ SCREW CATALOG #294.786 ON THE TIBIA. THE SCHANZ SCREW WAS BEING INSERTED USING THE POWER ADAPTOR 393.103 FROM THE LG EX-FIX TRAY. THE SURGEON HAD PREDRILLED THE HOLE WITH A 3.5 DRILL. THE PIN HIT THE FAR CORTEX AND STOPPED THE DRILL. THE PIN BECAME STUCK IN THE POWER ADAPTOR AND COULD NOT BE REMOVED. WE HAD TO CUT THE PIN WITH THE ADAPTOR IN ORDER TO CONTINUE WITH THE CASE. THERE WAS A 30 MINUTES OF SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 20170115 ↗
• 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 2 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7887315 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL OF EXFIX SCHANZ PIN FROM THE PROXIMAL ONE-THIRD OF THE FEMUR DUE TO AN INFECTED PIN SITE. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE PIN ON (B)(6) 2018. THE PIN SITE WAS CLEANED AND A NEW PIN WAS PLACED ON A DIFFERENT SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR A 5.0MM SELF-DRILLING SCHANZ SCREW 80MM THRD/200MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7611419 ↗
• 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 6 OF 7 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7427540 ↗
• 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 1 OF 7 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7427471 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082650, K122455, K161417, K952296. One submission often covers many models, so check the product and lot details in each record.

• Z-0043-2018 · Sep 18, 2017 · Terminated
  MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction
• 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.