REFLEX HYBRID 48510800Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327270914), received between Feb 18, 2022 and Jun 1, 2022 — classified as 2 malfunctions.

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

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.

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.

• MalfunctionJun 1, 2022Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT A REFLEX-HYBRID SCREWDRIVER AND REFLEX-HYBRID FINAL TIGHTENING SCREWDRIVER BROKE DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE REFLEX-HYBRID SCREWDRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14570095 ↗
• MalfunctionFeb 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT A REFLEX-HYBRID SCREWDRIVER "BROKE" INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559997 ↗