ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KITRecalls & reported problems across all models

We found 2 models of ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT by Orthofix Srl in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, 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 at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT problems

ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT 1

  Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
  1 recall2 reports
• ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT 1

  Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
  1 recall0 reports

Recent ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT adverse event reports

The 2 most recent reports across all models, 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 ↗

Other Orthofix Srl products

• VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM140 models · 5 reports · 20 recalls
• ORTHOFIX MODULSYSTEM15 models · 13 reports · 4 recalls
• Orthofix TrueLok Hexapod System (TL-HEX) V2.015 models · 45 reports · 1 recall
• Galaxy Unyco4 models · 0 reports · 1 recall
• FITBONE TAA SYSTEM10 models · 32 reports
• CHIMAERA Hip Fracture System16 models · 30 reports