NA 03.019.028Recalls & reported problems
Synthes GmbH · COMBINED HAMMER 360 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 10886982069689), received between Apr 18, 2022 and Apr 18, 2022 — 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.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2022Break; Break
IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, IT WAS OBSERVED THAT A COMBINED HAMMER 360 GRAMS WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A COMBINED HAMMER 360 GRAMS, THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14137521 ↗
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 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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