NA 399.42Recalls & reported problems
Synthes GmbH · HAMMER 500 GRAMS · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes surgical hammer is used to break bone during surgery. The 39 reports mostly describe problems found while reprocessing the instrument in sterile processing: handles staining the blue sterilization wrap, along with contamination, cracking, and leaking. There are 39 malfunctions, no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10886982202802), received between Dec 30, 2016 and Sep 25, 2024 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (17 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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem17
- Break10
- Leak/Splash10
- Device Contamination with Chemical or Other Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- No Patient Involvement16
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE HANDLES ON THE HAMMERS ARE STAINING THE BLUE WRAP. THE EVENT OCCURRED DURING THE FIELD INSPECTION IN STERILE PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20301655 ↗MalfunctionSep 24, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE HANDLES ON THE HAMMERS ARE STAINING THE BLUE WRAP. THE EVENT OCCURRED DURING THE FIELD INSPECTION IN STERILE PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20296844 ↗MalfunctionSep 24, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE HANDLES ON THE HAMMERS ARE STAINING THE BLUE WRAP. THE EVENT OCCURRED DURING THE FIELD INSPECTION IN STERILE PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20296257 ↗MalfunctionSep 24, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE HANDLES ON THE HAMMERS ARE STAINING THE BLUE WRAP. THE EVENT OCCURRED DURING THE FIELD INSPECTION IN STERILE PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20296213 ↗MalfunctionSep 24, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE HANDLES ON THE HAMMERS ARE STAINING THE BLUE WRAP. THE EVENT OCCURRED DURING THE FIELD INSPECTION IN STERILE PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20296160 ↗MalfunctionSep 24, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE HANDLES ON THE HAMMERS ARE STAINING THE BLUE WRAP. THE EVENT OCCURRED DURING THE FIELD INSPECTION IN STERILE PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20296152 ↗MalfunctionSep 24, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE HANDLES ON THE HAMMERS ARE STAINING THE BLUE WRAP. THE EVENT OCCURRED DURING THE FIELD INSPECTION IN STERILE PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20296133 ↗MalfunctionSep 24, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE HANDLES ON THE HAMMERS ARE STAINING THE BLUE WRAP. THE EVENT OCCURRED DURING THE FIELD INSPECTION IN STERILE PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20296131 ↗MalfunctionJun 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THE HAMMERS HAVE RESIDUE ON THEM THAT REMAINS POST CLEANING. NO SURGICAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE HAMMER 500 GRAMS. THIS IS REPORT 10 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19510331 ↗MalfunctionJun 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THE HAMMERS HAVE RESIDUE ON THEM THAT REMAINS POST CLEANING. NO SURGICAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE HAMMER 500 GRAMS THIS IS REPORT 9 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19510290 ↗MalfunctionJun 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THE HAMMERS HAVE RESIDUE ON THEM THAT REMAINS POST CLEANING. NO SURGICAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE HAMMER 500 GRAMS. THIS IS REPORT 8 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19510120 ↗MalfunctionJun 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THE HAMMERS HAVE RESIDUE ON THEM THAT REMAINS POST CLEANING. NO SURGICAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE HAMMER 500 GRAMS THIS IS REPORT 7 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19509992 ↗MalfunctionJun 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THE HAMMERS HAVE RESIDUE ON THEM THAT REMAINS POST CLEANING. NO SURGICAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE HAMMER 500 GRAMS THIS IS REPORT 5 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19509859 ↗MalfunctionJun 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THE HAMMERS HAVE RESIDUE ON THEM THAT REMAINS POST CLEANING. NO SURGICAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE HAMMER 500 GRAMS. THIS IS REPORT 3 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19509271 ↗MalfunctionJun 7, 2023Break; Break
IT WAS REPORTED THAT ON MAY 23,2023 THE PART OF HAMMER WAS BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) HAMMER 500 GRAMS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17082372 ↗MalfunctionApr 4, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 16-MARCH-2023, THE HANDLE OF THE HAMMER IN QUESTION LEFT BEHIND A GREASY DEPOSIT AFTER BEING STERILIZED. THERE WAS NO REPORTED PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HAMMER 500 GRAMS. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16674878 ↗MalfunctionApr 4, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 16-MARCH-2023, THE HANDLE OF THE HAMMER IN QUESTION LEFT BEHIND A GREASY DEPOSIT AFTER BEING STERILIZED. THERE WAS NO REPORTED PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HAMMER 500 GRAMS. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16674876 ↗MalfunctionMar 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE HAMMER SEEMS TO LEAVE STAINS IN STERI PEEL AFTER BEING STERILIZED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. IT WAS UNKNOWN IF THE SURGERY WAS SUCCESSFULLY COMPLETED OR NOT. IT WAS UNKNOWN IF ANY FRAGMENTS WERE GENERATED. THIS COMPLAIN INVOLVES THREE (3) DEVICE. THIS REPORT IS FOR ONE (1) HAMMER 500 GRAMS THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16517641 ↗MalfunctionFeb 6, 2023Break; Break
IT WAS REPORTED THAT ON JANUARY 16, 2023, IT WAS DISCOVERED THAT THE HANDLE WAS BROKEN IN HALF. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) HAMMER 500 GRAMS. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16305519 ↗MalfunctionJun 3, 2022Break; Break
IT WAS REPORTED ON UNKNOWN DATE THAT THE MALLET HEAD BROKE OFF. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN THIS REPORT IS FOR ONE (1) HAMMER 500 GRAMS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14594690 ↗MalfunctionDec 20, 2021Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HAMMER WAS DISCOVERED TO HAVE A CRACK IN THE HANDLE. THERE IS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A HAMMER 500 GRAMS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13047639 ↗MalfunctionDec 10, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) HAMMER 500 GRAMS FOUND WITH BROKEN HANDLES DURING ROUTINE INSPECTION. NO PATIENT INVOLVEMENT. THIS COMPLAINT TWO (2) DEVICES. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10985053 ↗MalfunctionDec 10, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) HAMMER 500 GRAMS FOUND WITH BROKEN HANDLES DURING ROUTINE INSPECTION. NO PATIENT INVOLVEMENT. THIS COMPLAINT TWO (2) DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10985038 ↗MalfunctionOct 27, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE HAMMERS WERE CRACKED AND BROKEN. IT WAS DISCOVERED DURING ROUTINE INSPECTION OF THE TRAYS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 HAMMER 500 GRAMS. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 10740625 ↗MalfunctionOct 27, 2020Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE HAMMERS WERE CRACKED AND BROKEN. IT WAS DISCOVERED DURING ROUTINE INSPECTION OF THE TRAYS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HAMMER 500 GRAMS. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 10740611 ↗
Other HAMMER, SURGICAL devices
- NA A6779Depuy (Ireland) · HAMMER, SURGICAL128 reports
- SUMMIT 2570-05-250Depuy (Ireland) · HAMMER, SURGICAL100 reports
- NA 03.010.522Synthes GmbH · HAMMER, SURGICAL68 reports
- NA 399.43Synthes GmbH · HAMMER, SURGICAL37 reports
- NA 03.010.170Synthes GmbH · HAMMER, SURGICAL37 reports
- NA 359.218Synthes GmbH · HAMMER, SURGICAL35 reports
- NA 03.010.056Synthes GmbH · HAMMER, SURGICAL27 reports
- GLOBAL ADVANTAGE 2128-01-025Depuy (Ireland) · HAMMER, SURGICAL23 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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