AESCULAP FK906RRecalls & reported problems
Aesculap AG · KERRISON Bone Punch conventional, 130 °, upwards cutting, 7", (180 mm), width: 1 mm, opening width: 8 mm, detachable, without ejector, thin, non-sterile, reusable, to be used with: JF120R · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653299690), received between Nov 30, 2022 and Dec 1, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 1, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED TO AESCULAP INC. THAT A KERRISON DET130 DEG UP 1MM 180MMTHP (ITEM # FK906R) WAS USED IN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING A PROCEDURE THE TIP OF THE DEVICE BROKE OFF. X-RAY WAS USED TO RETRIEVE THE BROKEN METAL TIP FROM THE PATIENT. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. HOWEVER, A SURGICAL DELAY OF FIFTEEN (15) MINUTES WAS NOTED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15896171 ↗InjuryNov 30, 2022Fracture; Fracture
IT WAS REPORTED TO AESCULAP INC. THAT A KERRISON DET130 DEG UP 1MM 180MMTHP (ITEM # FK906R) WAS USED DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE DEVICE BROKE OFF. X-RAY WAS USED TO RETRIEVE THE FRAGMENT FROM THE PATIENT. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. HOWEVER, A SURGICAL DELAY OF FIFTEEN (15) MINUTES WAS NOTED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15890524 ↗
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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