Galaxy Fixation System 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 18033509859878), received between Mar 7, 2018 and Mar 21, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

13 other recalls cover devices cleared under the same FDA submission (K113770); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2018Break; Break

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: DR. (B)(6); DATE OF SURGERY: (B)(6) 2018; BODY PART TO WHICH DEVICE WAS APPLIED: LEFT PROXIMAL HUMERUS; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT'S INFORMATION: (B)(6) YEAR-OLD, MALE, WEIGHT (B)(6) KG, HEIGHT 165 CM, PREVIOUS HEALTH CONDITION: GOOD; PROBLEM OBSERVED DURING CLINICAL USE ON PATIENT; EVENT DESCRIPTION: "THE WIRE BROKE DURING INSERTION. THE SURGEON WAS ABLE TO REMOVE THE PORTION OF THE WIRE IN THE HUMERUS." NOTES: THE BROKEN WIRE WAS DISCARDED. THE COMPLAINT REPORT FORM ALSO INDICATES: -THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. -THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. -THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. -AN ADDITIONAL SURGERY WAS NOT REQUIRED. -COPY OF OPERATIVE REPORTS IS NOT AVAILABLE. -COPY OF X-RAY IMAGES IS AVAILABLE. -INFORMATION ON PATIENT CURRENT HEALTH CONDITION: GOOD. ON THE SAME DATE OF NOTIFICATION, ORTHOFIX (B)(4) RECEIVES COPY OF POST-OPERATIVE X-RAY IMAGES. MANUFACTURER REFERENCE NUMBER: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7356651 ↗
• MalfunctionMar 7, 2018Fracture; Fracture

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICE CODE: 99-93100; LOT NUMBER: B1215315; QUANTITY: 2 (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2018-00018); HOSPITAL NAME: (B)(6); SURGEON NAME: (B)(6); DATE OF SURGERY: (B)(6) 2018; BODY PART TO WHICH DEVICE WAS APPLIED: PROXIMAL HUMERUS; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT'S INFORMATION: (B)(6), FEMALE; PROBLEM OBSERVED DURING TREATMENT (DURING SURGERY); TYPE OF PROBLEM: OTHER; EVENT DESCRIPTION: "DURING INSERTION OF WIRES, TWO OF THEM BROKE WHERE THE THREAD ENDS. ONE PORTION OF ONE WIRE WAS LEFT IN THE PATIENT BONE. THE SECOND WIRE THAT BROKE WAS COMPLETELY REMOVED." THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE CAUSED ADVERSE EFFECTS TO PATIENT (UN-RETRIEVED DEVICE FRAGMENTS); THE SURGERY WAS COMPLETED WITH THE DEVICE; THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE (30 MINUTES DELAY; A SURGICAL EXPLORATION IS REQUIRED TO REMOVE THE UNRETRIEVED DEVICE FRAGMENT); AN ADDITIONAL SURGERY WAS NOT REQUIRED; COPIES OF OPERATIVE REPORTS ARE NOT AVAILABLE; COPIES OF THE X-RAY IMAGES ARE AVAILABLE; PATIENT CURRENT HEALTH CONDITIONS: GOOD. MANUFACTUR

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7319689 ↗
• MalfunctionMar 7, 2018Fracture; Fracture

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: (B)(4); LOT NUMBER: B1215315; QUANTITY: 2 (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2018-00019); HOSPITAL NAME: (B)(6); SURGEON NAME: (B)(6); DATE OF SURGERY: (B)(6) 2018; BODY PART TO WHICH DEVICE WAS APPLIED: PROXIMAL HUMERUS; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT'S INFORMATION: (B)(6), FEMALE; PROBLEM OBSERVED DURING TREATMENT (DURING SURGERY); TYPE OF PROBLEM: OTHER; EVENT DESCRIPTION: "DURING INSERTION OF WIRES, TWO OF THEM BROKE WHERE THE THREAD ENDS. ONE PORTION OF ONE WIRE WAS LEFT IN THE PATIENT BONE. THE SECOND WIRE THAT BROKE WAS COMPLETELY REMOVED." THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE CAUSED ADVERSE EFFECTS TO PATIENT (UN-RETRIEVED DEVICE FRAGMENTS); THE SURGERY WAS COMPLETED WITH THE DEVICE; THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE (30 MINUTES DELAY; A SURGICAL EXPLORATION IS REQUIRED TO REMOVE THE UNRETRIEVED DEVICE FRAGMENT); AN ADDITIONAL SURGERY WAS NOT REQUIRED; COPIES OF OPERATIVE REPORTS ARE NOT AVAILABLE; COPIES OF THE X-RAY IMAGES ARE AVAILABLE; PATIENT CURRENT HEALTH CONDITIONS: GOOD. (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7319688 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113770. One submission often covers many models, so check the product and lot details in each record.

• Z-2731-2026 · Jun 10, 2026 · Open, Classified
  Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
• Z-2732-2026 · Jun 10, 2026 · Open, Classified
  Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
• Z-2730-2026 · Jun 10, 2026 · Open, Classified
  Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
• Z-2729-2026 · Jun 10, 2026 · Open, Classified
  Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
• Z-0396-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281
• Z-0400-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
• Z-0401-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
• Z-0398-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895
• Z-0399-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
• Z-0402-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533
• Z-0394-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908
• Z-0395-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888
• Z-0397-2020 · Sep 27, 2018 · Terminated
  ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915