AESCULAP FK914RRecalls & reported problems
Aesculap AG · KERRISON Bone Punch conventional, 130 °, upwards cutting, 7 7/8", (200 mm), regular, width: 3 mm, opening width: 10 mm, detachable,with ejector, standard, non-sterile, reusable, to be used with: JF120R · Class 1
Data updated Oct 16, 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 04038653299751), received between Mar 29, 2021 and Mar 29, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Twisted/Bent1
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.
MalfunctionMar 29, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FK914R -KERRISON DET130 DEG UP 3MM 200MMREG. ACCORDING TO THE COMPLAINT DESCRIPTION, IT WAS REPORTED THAT THE KERRISON DET130 DEG UP 3MM 200MMREG MALFUNCTIONED DURING A LUMBAR LAMINECTOMY ON (B)(6) 2021. REPORTEDLY, THE DISTAL TIP OF THE UPPER SLIDING PORTION OF THE KERRISON IS PEELING (BENDING) BACKWARDS. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE DUE TO THE DEVICE FAILURE; THE TIME REQUIRED TO OPEN AN ADDITIONAL INSTRUMENT SET. THE INCIDENT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. THIS EVENT/MALFUNCTION PROLONGED THE SURGERY FOR 10 MINUTES. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11582869 ↗
Other PUNCH, SURGICAL devices
- SIGMA LCS HIGH PERFORMANCE 9505-02-012Depuy Orthopaedics, Inc. · PUNCH, SURGICAL85 reports
- SIGMA LCS 9505-02-018Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall10 reports
- DJO SURGICAL 801-05-040Encore Medical, L.P. · PUNCH, SURGICAL1 recall7 reports
- SIGMA LCS 9505-02-017Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall1 report
- SIGMA LCS 9505-02-016Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-021Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-020Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA HIGH PERFORMANCE 9505-02-047Depuy (Ireland) · PUNCH, SURGICAL33 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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