NOIR FK961BRecalls & reported problems
Aesculap AG · KERRISON NOIR Bone Punch conventional, 130 °, upwards cutting, 7 7/8", (200 mm), width: 1 mm, opening width: 8 mm, detachable, without ejector, thin, non-sterile, reusable · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04038653436811), received between May 20, 2021 and Sep 22, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Break
It was reported that a KERRISON DETACH 130DG UP 200MM 1MM THIN (Part # FK961B) was used during a procedure on (b)(6) 2026. Reportedly the tip of the device broke inside the patient during surgery. The staff was able to remove the broken piece and went through their hospital policies to make sure it had all been removed from the patientThis report is filed under or AIC reference (b)(4).
Patient problems: Insufficient Information
MAUDE report 50853436 ↗InjuryMay 21, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FK961B-KERRISON DETACH 130DG UP 200MM 1MM THIN. THE TIP OF THE DEVICE BROKE DURING USE IN A C4-C6 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE. THE BROKEN FRAGMENT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT AS THE PIECE WAS EASILY VISIBLE. AN X-RAY WAS NOT REQUIRED; THERE WAS LESS THAN 5 MINUTE DELAY REQUIRED TO REPLACE THE INSTRUMENT. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE FRAGMENT WAS NOTED TO BE EXTREMELY SMALL. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11863728 ↗InjuryMay 20, 2021Break; Break
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A KERRISON. THE TIP OF THE DEVICE BROKE DURING USE IN A C4-C6 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE. THE BROKEN FRAGMENT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT AS THE PIECE WAS EASILY VISIBLE. AN X-RAY WAS NOT REQUIRED; THERE WAS LESS THAN 5 MINUTE DELAY REQUIRED TO REPLACE THE INSTRUMENT. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THE FRAGMENT WAS NOTED TO BE EXTREMELY SMALL. THE ADVERSE EVENT IS FILED UNDER XC REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11856173 ↗
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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