ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT 1 (REF 99-93506)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18054242512325), received between May 4, 2016 and May 12, 2017 — classified as 2 injuries.

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

1 FDA recall record name this device's identifier.

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 18, 2026.

Recalls naming this device

1. Jul 5, 2017Class IITerminated

   The power drill torque limiter may break during use in surgery application.

   Z-0291-2018 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2017Fracture; Fracture

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: O HOSPITAL NAME: (B)(6); SURGEON'S NAME: UNAVAILABLE; O DATE OF INITIAL SURGERY: UNAVAILABLE; O BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA; O SURGERY DESCRIPTION: FRACTURE TREATMENT; O PATIENT'S INFORMATION: (B)(6), FEMALE; O PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; O TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: THE SURGEON WANTED TO IMPLANT FIXATOR ON POLYTRAUMATIZED PATIENT. WHEN FIXING THE SECOND SCREW, THE DYNAMOMETRIC TOOL GOT BROKEN. A REPLACEMENT KIT WAS AVAILABLE TO PERFORM THE SURGERY. IT HAS RESULTED IN LONGER SURGERY WITHOUT ANY CONSEQUENCE ON PATIENT. THE COMPLAINT FORM ALSO INDICATES: O THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT; O THE SURGERY WAS NOT COMPLETED WITH USED DEVICE; O A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY; O THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE; O AN ADDITIONAL SURGERY WAS NOT REQUIRED; O A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED; INFORMATION ON PATIENT CURRENT HEALTH CONDITION: NA. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 4 MAY, 201

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6562588 ↗
• InjuryMay 4, 2016Fracture; Fracture

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: PROF. DR. (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2016; BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA LEFT; SURGERY DESCRIPTION: NON UNION; PATIENT'S INFORMATION: AGE (B)(6), FEMALE; PREVIOUS HEALTH CONDITION: SEPTIC PSEUDOARTHROSIS AFTER OLD FRACTURE IN TIBIA; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: BREAKAGE OF THE TORQUE LIMITER WHILE INSERTING SCREW NO. 7. THE COMPLAINT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT; THE SURGERY WAS NOT COMPLETED WITH USED DEVICE; A REPLACEMENT DEVICE WAS NOT IMMEDIATELY AVAILABLE TO COMPLETE SURGERY -A UNIVERSAL CHUCK HANDLE WAS USED TO INSERT THE LAST SCREW; THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE; AN ADDITIONAL SURGERY WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE; COPIES OF X-RAY IMAGES ARE AVAILABLE; INFORMATION ON PATIENT CURRENT HEALTH CONDITION: PATIENT IS FINE. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5629888 ↗