REFLEX HYBRID 48510420Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327270761), received between May 31, 2018 and Mar 23, 2022 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PIN OF A REFLEX HYBRID TEMPORARY FIXATION PIN BROKEN OFF OF THE INSTRUMENT DURING CLEANING OUTSIDE OF THE OR. THERE WAS NO ASSOCIATED PROCEDURE WITH THIS EVENT, THEREFORE, NO ADVERSE CONSEQUENCES TO ANY PATIENTS OR SURGICAL DELAYS WERE SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869777 ↗
• MalfunctionFeb 22, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT A REFLEX-HYBRID FIXATION PIN AND SCREW EXTRACTOR INNER SHAFT WERE OBSERVED TO BE BENT OUTSIDE THE OPERATING ROOM. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED. THIS REPORT WILL CAPTURE THE PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577966 ↗
• MalfunctionMay 31, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT A HYBRID FIXATION PIN THAT WAS BEING USED TO HOLD THE PLATE IN PLACE BROKE OFF IN THE PATIENT. IT WAS REMOVED WITH A SCREW REMOVAL SET. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7558621 ↗