NOIR FK906BRecalls & reported problems
Aesculap AG · KERRISON NOIR 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04038653405459), received between Jun 21, 2021 and Aug 24, 2021 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (3 reports).
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 Fragmentation3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2021Material Fragmentation; Material Fragmentation
NO UPDATES REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12359631 ↗InjuryAug 24, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED TO AESCULAP INC. THAT A KERRISON BLK COATED 130 UP 180X1MM THIN (PART # FK906B) WAS USED DURING A C5-C7 ANTERIOR CERVICAL DISC FUSION PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE SURGERY, THE TIP OF THE KERRISON BROKE OFF. THE PHYSICIAN FOUND AND RETRIEVED THE DEVICE FRAGMENTS, AND THEN THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER (B)(4) REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12359089 ↗MalfunctionJun 21, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FK906B - KERRISON BLK COATED 130 UP 180X1MM THIN AS PER INFORMATION RECEIVED VIA MEDWATCH (B)(4). ACCORDING TO THE COMPLAINT DESCRIPTION, RONGEUR WAS IN USE DURING SURGERY, DOCTOR NOTICED THE TIP WAS LOOSENED. THE TIP DID NOT BREAK OFF COMPLETELY UNTIL IN THE POSSESSION OF THE RIKS COORDINATOR. AN ADDITIONAL RONGEUR WAS USED TO COMPLETE THE SURGERY. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12033747 ↗
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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