ITOTAL IDENTITY IMPACTOR HANDLE 1080-212Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00810933030582), received between Dec 28, 2022 and Apr 24, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 14, 2022Class IIOpen, Classified

   Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.

   Z-1133-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2024Structural Problem; Misassembly by Users; Structural Problem; Misassembly by Users

  THE IMPACTOR HANDLE SCREW CAME OUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172822 ↗
• MalfunctionSep 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE COMPLAINT REPORTS THAT A SCREW FELL OUT OF THE IMPACTOR HANDLE, ED-07827, DURING SURGERY AND LANDED ON THE FLOOR AFTER IMPACTING THE KEEL PUNCH INTO THE TIBIA. THERE WAS NO IMPACT TO THE SURGERY AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17754933 ↗
• InjuryJun 14, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT AN IMPACTOR HANDLE HAD A BROKEN BUTTON MECHANISM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17126908 ↗
• InjuryMay 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE COMPLAINT REPORTS AN IMPACTOR HANDLE, ED-07827, DIDN'T WORK DURING SURGERY. THE SURGERY WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH A BACKUP DEVICE WITH A 15 MINUTE DELAY BUT NO IMPACT WAS REPORTED TO THE OUTCOME OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16878658 ↗
• InjuryMar 8, 2023Device Dislodged or Dislocated; Misassembly by Users; Device Dislodged or Dislocated; Misassembly by Users

  IT WAS REPORTED THAT A SCREW CAME LOOSE FROM AN IMPACTOR HANDLE AND WAS ABLE TO BE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501981 ↗
• MalfunctionJan 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SET SCREW DISLODGED FROM LOCKING MECHANISM ON THE UNIVERSAL IMPACTOR HANDLE DURING TIBIAL COMPONENT IMPLANTATION AND FELL IN TO THE JOINT. THE SMALL SCREW WAS LOCATED AND REMOVED BEFORE CLOSURE. THERE WAS A BRIEF DELAY AND NO INJURY OR HARM. 1080-212 ITOTAL IDENTITY IMPACTOR HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16258855 ↗
• InjuryDec 28, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WE RECEIVED POST-OP X-RAYS TODAY OF DR. (B)(6) PATIENT WHO APPEARS TO HAVE HAD A SCREW IMPLANTED IN THEIR TIBIA ALONG WITH THEIR CONFORMIS IMPLANT. THE IMPACTOR HANDLE THAT WAS USED DURING SURGERY IS ALSO MISSING ONE OF ITS SET SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064547 ↗