Galaxy UNYCO System 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18054242513629), received between Aug 11, 2016 and Apr 5, 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 16, 2026.

Recalls naming this device

1. Jul 5, 2017Terminated

   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.

• InjuryApr 5, 2017Fracture; Fracture

  EVENT OCCURRED DURING POST-MARKET CLINICAL STUDY (REF: (B)(6)) THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: CLINIC (B)(6); SURGEON NAME: DR. (B)(6); DATE OF SURGERY: (B)(6) 2017; BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA; SURGERY DESCRIPTION: NON UNION; PATIENT'S INFORMATION: NOT AVAILABLE; PREVIOUS HEALTH CONDITION: HEALTHY; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: BREAKAGE OF TORQUE LIMITER DURING INSERTION WITH POWER DRILL. EASY SOLUTION: OPENED A NEW ONE. 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 IMMEDIATELY AVAILABLE TO COMPLETE SURGERY; 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 NOT AVAILABLE; INFORMATION ON PATIENT CURRENT HEALTH CONDITION: OK, NO PAIN/PROBLEMS. NOTE AND COMMENTS: RECOVERED DURING REPLENISHMENT -NO SURGERY INVOLVED. INCREASED SURGERY TIME ABOUT 5 MIN DUE T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6459691 ↗
• InjuryAug 11, 2016Fracture; Fracture

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2016; BODY PART TO WHICH DEVICE WAS APPLIED: ANKLE-TIBIA; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT'S INFORMATION: (B)(6) YEARS OLD, MALE, WEIGHT (B)(6); PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: "WHEN IMPLANTING THE THIRD SCREW, THE DYNAMO SCREWDRIVER GOT BROKEN. THIS HAPPENED ON FRACTURE SURGERY ON ANKLE - TIBIA. THERE IS A RISK FOR LEAVING SMALL PARTS IN FRACTURE." THE COMPLAINT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: UN-RETRIEVED DEVICE FRAGMENTS. THE SURGERY COULD BE COMPLETED WITH USED DEVICE. 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 OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF X-RAYS ARE NOT AVAILABLE. INFORMATION ON PATIENT'S CURRENT HEALTH CONDITION: PATIENT SEEMS TO BE OK. THERE SHOULD NOT BE ANY IMPACT FOR HIM AS SALES REPRESENTATIVE STATES. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 27TH JULY,

  Patient problems: No Code Available

  MAUDE report 5867894 ↗