NA 399.54Recalls & reported problems
Synthes GmbH · CHISEL HANDLE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982202895), received between Feb 22, 2019 and Mar 18, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
- Defective Device1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2024Defective Device; Device-Device Incompatibility; Defective Device; Device-Device Incompatibility
IT WAS REPORTED ON (B)(6) 2024, THAT THE SET SCREW WAS NOT THE CORRECT SIZE FOR THE SCREWDRIVER. THERE WERE NO PATIENT INVOLVEMENT AND CONSEQUENCES. THIS REPORT IS FOR ONE (1) UNK - SCREWDRIVERS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18920884 ↗MalfunctionMar 1, 2024Break; Break
IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SET SCREW FOR CHISEL HANDLE CAME APART. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) CHISEL HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18820155 ↗MalfunctionMar 8, 2019Break; Break
IT WAS REPORTED ON (B)(6) 2019, THE CHISEL HANDLE BOLT WAS MISSING. IT IS UNKNOWN WHERE THE ISSUE WAS DISCOVERED. PROCEDURE AND PATIENT INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR A CHISEL HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8405032 ↗MalfunctionFeb 22, 2019Break; Break
IT WAS REPORTED THAT DURING DECONTAMINATION ON AN UNKNOWN DATE, THE SCREW OF THE CHISEL HANDLE THAT TIGHTENS DOWN AND KEEPS THE BLADE INTACT HAD FALLEN OFF. IT WAS STILL IN THE THREAD OF THE HANDLE. SALES CONSULTANT THOUGHT THE EVENT MOST LIKELY DID NOT HAPPEN DURING A PROCEDURE, BUT AFTERWARD WHEN THE INSTRUMENT WAS TAKEN APART, POTENTIALLY BY SOMEBODY WHO WAS NEW WHO DID NOT KNOW HOW TO TAKE APART THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE: CHISEL BLADE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A CHISEL HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8361588 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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