PROFYLE 59-23010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 34546540244865), received between Nov 25, 2020 and Nov 25, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2020Fracture; Fracture

  AS REPORTED, "ON (B)(6) 2020, AT 9:00 A.M., THE PATIENT CAME TO OUR HOSPITAL WITH A FRACTURE OF THE RIGHT LITTLE FINGER FOR "RIGHT LITTLE FINGER INCISION AND INTERNAL FIXATION." DURING THE OPERATION, THE SURGEON INSTALLED THE STEEL PLATE, AND FIXED IT WITH SCREWS. DURING THE PROCESS OF TIGHTENING THE SCREWS, THE SCREW CAP PARTLY BROKE AND FRACTURED, THE BROKEN PART FELL INTO THE INCISION WOUND. REMOVE THE BROKEN PART IMMEDIATELY WITH FORCEPS, RINSE THE WOUND WITH SALINE, REPLACE A SCREW AND CONTINUE THE PROCEDURE. DURING THE SUBSEQUENT INSTALLATION OF THE SCREW, OPERATE AS GENTLY AS POSSIBLE. THIS EVENT RESULTED IN PROLONGED OPERATIVE TIME.(DUE TO TIME CONSTRAINTS AND THE NEED FOR STERILITY DURING THE OPERATION, THE BROKEN SCREW WAS THROWN INTO THE MEDICAL WASTE BIN DURING THE OPERATION WITHOUT BEING PHOTOGRAPHED, AND MEDICAL WASTE WAS CLEANED UP IMMEDIATELY AFTER THE OPERATION TO PREPARE FOR THE NEXT OPERATION BY THE LOGISTICIAN)." ADDITIONALLY REPORTED: DELAY ONE HALF AN HOUR. PATIENT IS HARD BONE. NO ADDITIONAL ANESTHESIA DUE TO THE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10900761 ↗