NA 394.055Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982199478), received between Jan 23, 2018 and Jun 23, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K063832, K090658); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT EXTERNAL SKELETAL FIXATION FOR SUPRACONDYLAR HUMERUS FRACTURE WITH THE ELBOW HINGE FIXATOR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. HOWEVER, IT WAS REPORTED THAT ON (B)(6) 2025, THE SCREW OF THE ELBOW HINGE FIXATOR CAME OFF AND FELL APART. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308159 ↗
• InjuryAug 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON COMPLAINED THAT THE JOINT REGULARLY COMES APART ON THE MOTION FIXATORS, CREATING THE NEED FOR REWORK ON PATIENTS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN ELBOW HINGE FIXATOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15293795 ↗
• InjuryDec 31, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT CAME IN WITH AN ELBOW HINGE FIXATOR THAT HAD BROKEN APART. IT WAS OBSERVED THAT THERE WAS A BLANK IN BETWEEN AND THAT CAME APART. INITIALLY, ON (B)(6) THE PATIENT CAME IN FOR DISTAL CASE OF THE ELBOW AND FRACTURE OF THE RADIAL HEAD AND DISTAL HUMERUS. A RADIAL HEAD PROSTHESIS AND DISC HUMERUS PLATE FROM OTHER COMPANY WAS APPLIED TO THE PATIENT TOGETHER WITH SYNTHES DEVICES WHICH ARE UNKNOWN DISC, AN ELBOW AND AN INTERNAL FIXATION WITH AN ELBOW HINGE FIXATOR. IT IS UNKNOWN IF THERE WAS A PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN RADIAL HEAD PROSTHESIS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN DISC HUMERUS PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN DISC (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9536305 ↗
• InjuryJun 13, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ELBOW HINGE FIXATOR BROKE IN THE PATIENT. IMPLANT WAS REMOVED. INITIAL DATE OF SURGERY WAS ON (B)(6) 2019. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN EXTERNAL-FIXATOR CLAMPS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1); UNKNOWN RODS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). UNKNOWN SCHANZ SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8695924 ↗
• InjuryDec 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CENTRAL AXIAL OF AN ELBOW HINGE FIXATOR HAD FALLEN OUT OF THE HINGES. THE PATIENT NOTIFIED THE SURGEON ON (B)(4) 2018 ABOUT THE COMPLICATION. IMPLANT DATE WAS (B)(6) 2018. PATIENT SUPPLEMENTED THE FAILED DEVICE WITH A COMMON HARDWARE SCREW AND NUT TO HOLD THE ELBOW FIXATOR IN PLACE UNTIL A NEW ONE COULD BE AFFIXED. THE SURGEON THEN REPLACED AN ELBOW HINGE FIXATOR ON (B)(6) 2018 IN THE CLINIC. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT HAD DELAYED HEALING AND ADDITIONAL CLINIC VISITS WITH THE POSSIBILITY FOR AN ADDITIONAL SURGERY. THIS REPORT IS FOR ONE (1) ELBOW HINGE FIXATOR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8162368 ↗
• InjuryAug 22, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT DURING A FOLLOW UP CHECK UP ON AN UNKNOWN DATE, THE METAL SLEEVE ON THE EXTERNAL FIXATOR WAS NOTICED TO LOOSEN. THE LOOSENING WAS IDENTIFIED SIX WEEKS AFTER THE INITIAL SURGERY DUE TO AN UNSTABLE ELBOW. THE SURGEON TIGHTENED AND TAPED THE SLEEVE TO PREVENT IT FROM LOOSENING AGAIN SO THAT THE PATIENT COULD CONTINUE TO WEAR IT FOR ANOTHER THREE WEEKS. THE SURGEON REMOVED THE FIXATOR ON (B)(6) 2018, AFTER THE INJURY WAS COMPLETELY HEALED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THE PATIENT'S CONDITION WAS FINE AFTER THE PROCEDURE. THIS REPORT IS FOR ONE (1) ELBOW HINGE FIXATOR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7806999 ↗
• InjuryApr 3, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT AN ELBOW HINGE FIXATOR SOMEHOW UNSCREWED AND FELL OUT OF A PATIENT ON (B)(6) 2018. LUCKILY THE PATIENT WAS STILL IN RECOVERY AT THE HOSPITAL AND THE SURGEON WAS ABLE TO IMPLANT THE PATIENT WITH A NEW ELBOW HINGE FIXATOR THAT SAME DAY. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE HINGE ON AN UNKNOWN DATE THE WEEK OF (B)(6) FEBRUARY. NO INFORMATION IS AVAILABLE ABOUT THE ORIGINAL PROCEDURE. THE MARCH 4TH PROCEDURE WAS REPORTED TO BE SUCCESSFULLY COMPLETED WITH NO COMPLICATIONS OR DELAYS. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION FOLLOWING THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(6).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7391945 ↗
• InjuryJan 23, 2018Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT HAD A PROCEDURE ON (B)(6) 2017 FOR A FRACTURE OF CORONOID. POST-OPERATIVELY, THE JOINT OF THE HINGE ON THE ELBOW FIXATOR FELL APART. REVISION FOR HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2018 WHERE THE ELBOW FIXATOR WAS REMOVED AND NEW PARTS WERE IMPLANTED. THERE WAS NO SURGICAL DELAY. PATIENT STATUS/OUTCOME WAS SUCCESSFUL AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVE 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7214255 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063832, K090658. One submission often covers many models, so check the product and lot details in each record.

• Z-1833-2014 · Apr 10, 2014 · Terminated
  Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.