NA 357.22Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982195913), received between Mar 31, 2021 and May 30, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 30, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED ON MAY 1 2024, THE EXTRACTION SCREW AND SLAP HAMMER GUIDE WERE CROSSED THREADED. AFTER IMPACTION, THEY COULD NOT BE DISASSEMBLED. THE SURGERY WAS DELAYED 14 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) HAMMER GUIDE FOR SLIDE HAMMER THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19432004 ↗
• MalfunctionAug 31, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE UNIVERSAL CHUCK, SCREWDRIVER SHAFT, HAMMER GUIDE, STARDRIVE SCREWDRIVER SHAFT, CANNULATED HEXAGONAL SCREWDRIVER, THREADED ROD AND UNIVERSAL CHUCK WITH T-HANDLE ARE FOUND BROKEN DURING THE INSPECTION OUTSIDE THE SURGERY. PATIENT INVOLVEMENT IS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) HAMMER GUIDE FOR SLIDE HAMMER. THIS REPORT IS 4 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392774 ↗
• MalfunctionMar 31, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HAMMER GUIDE FOR SLIDE HAMMER HAD BROKEN THREADS. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) HAMMER GUIDE FOR SLIDE HAMMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599245 ↗