AESCULAP FK894RRecalls & reported problems
Aesculap AG · KAIRISON Bone Punch pneumatic, upwards cutting, 11 1/4", (285 mm), working length: 7 1/2", (190 mm), width: 4 mm, opening width: 12mm, detachable, with ejector, non-sterile, reusable, to be used with: FK891R · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963329624), received between Nov 17, 2021 and Nov 17, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation1
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.
InjuryNov 17, 2021Material Fragmentation; Material Fragmentation
NO CHANGES REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12829418 ↗
Other RONGEUR, POWERED devices
- AESCULAP FK882RAesculap AG · RONGEUR, POWERED1 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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