NA MAI001Recalls & reported problems
Depuy (Ireland) · INERTIA MASS · 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 10603295262770), received between Oct 9, 2018 and Jul 12, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility2
- Naturally Worn2
- Entrapment of Device1
- Material Twisted/Bent1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 12, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO . B. PLEASE CONFIRM WHEN THE EVENT OCCURRED? POST OP. C. WHAT IS THE ALLEGATION WITH THE SLAP HAMMER? IT IS ALL JAMMED AND NOT ABLE TO SEPARATE THREADS APPEAR TO BE DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17304759 ↗MalfunctionJun 2, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
VARIOUS ITEMS HAVE BEEN IDENTIFIED AS NEEDING TO BE REPLACED DUE TO WEAR AND TEAR. NO IMPACT TO PATIENT BUT THESE ARE NO LONGER VIABLE TO USE AND NEED TO BE REPLACED FOR AN UPCOMING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11920741 ↗MalfunctionMar 26, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
CORAIL EXTRACTION INSTRUMENTS COLD - WELDED TOGETHER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9883381 ↗MalfunctionOct 9, 2018Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT STEM REMOVAL TOOL THREADS ARE STRIPPED AND COLD WELDED TO THE SLAP HAMMER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7947623 ↗
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 399.42Synthes GmbH · HAMMER, SURGICAL39 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
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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