AESCULAP FK987RRecalls & reported problems
Aesculap AG · KERRISON Bone Punch conventional, 130 °, upwards cutting, 11", (280 mm), width: 3 mm, opening width: 10 mm, detachable, with ejector, standard, non-sterile, reusable · Class 1
Data updated Oct 18, 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 04046964508714), received between Dec 1, 2020 and Dec 1, 2020 — 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 18, 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.
MalfunctionDec 1, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FK987R-KERRISON DET130 DEG UP 3MM 280MM. IT WAS REPORTED THAT THE TOP OF THE KERRISON DET130 DEG UP 3MM 280MM DEVICE'S CUTTING EDGE (THE LIP ACROSS THE SHARP CUTTING SURFACE THAT GOES AGAINST THE FOOTPLATE) BENT BACK DURING A LAMINECTOMY PROCEDURE ON (B)(6) 2020. THIS WAS REPORTEDLY THE FIRST TIME THE DEVICE HAS BEEN USED. WHILE AN ALTERNATIVE DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE AND THERE WAS NO SURGICAL DELAY THERE IS A CONCERN AS THE DEVICES SEEM LIKE THEY CANNOT CUT AT ALL. THE REPORTED EVENT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10929478 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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