NA 03.010.059Recalls & reported problems
Synthes GmbH · HAMMER GUIDE FOR SLIDE/FIXED HAMMER 400 GRAMS · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982067302), received between Mar 19, 2024 and Mar 19, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2024Break; Break
IT WAS REPORTED ON (B)(6) 2024, A ORTHOPEDIC SURGEON USED A HAMMER TO EXTRACT HARDWARE DURING SURGERY. DURING ONE STRIKE OF THE HAMMER, THE HANDLE OF THE HAMMER BROKE INTO "A COUPLE PIECES" IN THE SURGEON'S HAND. SURGICAL DELAY UNKNOWN AND PATIENT CONSEQUENCE UNKNOWN. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME. THIS REPORT IS FOR ONE HAER GUIDE SLIDE/FIXED HAER 400 GRAMS; THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 18934276 ↗
Other MALLET devices
- KMEDIC IPN013965Teleflex Incorporated · MALLET3 reports
- TC-PLUS / RT-PLUS 75100394Smith & Nephew, Inc. · MALLET2 reports
- V. Mueller OS1512Steris Corporation · MALLET1 report
- Integra® Jarit® 250404Integra Lifesciences Production Corporation · MALLET1 report
- Integra® Miltex® 19-790Integra Lifesciences Production Corporation · MALLET1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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