SPECIALIST 96-6530Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295248668), received between May 16, 2019 and Nov 3, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ANGEL WINGS ARE BENT ON THIS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065044 ↗
• MalfunctionNov 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ANGEL WINGS ARE BENT ON THIS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065035 ↗
• MalfunctionJun 28, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE GUIDE IS BENT. NO PATIENT IMPACT, NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14840809 ↗
• MalfunctionJun 27, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE GUIDE IS BENT. NO PATIENT IMPACT, DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14829222 ↗
• MalfunctionMar 11, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THE HOSPITAL HAVE REPORTED THAT THE INSTRUMENT METAL BENT AND UNABLE TO SLIDE THROUGH SLOTS. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13732701 ↗
• MalfunctionAug 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ADJUSTMENT DIAL WAS A LITTLE BENT AND NO LONGER FUNCTIONED. NO DELAY TO SURGERY OR PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12286769 ↗
• MalfunctionMay 17, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PARTS HAVE BENT OVER YEARS OF USE AND WON'T TAKE ORIGINAL SHAPE. NEED TO BE STRAIGHT TO WORK PROPERLY. THEY WERE DISCARDED BY HOSPITAL. NO SURGERY DONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8619631 ↗
• MalfunctionMay 17, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PARTS HAVE BENT OVER YEARS OF USE AND WON'T TAKE ORIGINAL SHAPE. NEED TO BE STRAIGHT TO WORK PROPERLY. THEY WERE DISCARDED BY HOSPITAL. NO SURGERY DONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8619608 ↗
• MalfunctionMay 17, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PARTS HAVE BENT OVER YEARS OF USE AND WON'T TAKE ORIGINAL SHAPE. NEED TO BE STRAIGHT TO WORK PROPERLY. THEY WERE DISCARDED BY HOSPITAL. NO SURGERY DONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8619601 ↗
• MalfunctionMay 17, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PARTS HAVE BENT OVER YEARS OF USE AND WON'T TAKE ORIGINAL SHAPE. NEED TO BE STRAIGHT TO WORK PROPERLY. THEY WERE DISCARDED BY HOSPITAL. NO SURGERY DONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8619578 ↗
• MalfunctionMay 16, 2019Material Twisted/Bent; Material Twisted/Bent

  INSTRUMENT WAS REPORTED TO HAVE BEEN BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8616683 ↗
• MalfunctionMay 16, 2019Material Twisted/Bent; Material Twisted/Bent

  INSTRUMENT WAS REPORTED TO HAVE BEEN BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8616071 ↗