REFLEX HYBRID 48510810Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327270921), received between Apr 25, 2016 and Jun 1, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 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 FINAL TIGHTENING SCREWDRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14570135 ↗
• MalfunctionApr 25, 2016Break; Detachment Of Device Component; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE TIP OF A FINAL TIGHTENER BROKE OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5606387 ↗