SPOTLIGHT 292902240Recalls & reported problems
Depuy Spine, LLC · SPOTLIGHT ACCESS SYSTEM 40 DEGREES KERRISON RONGEUR 2mm · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034225463), received between Oct 30, 2019 and Feb 1, 2024 — classified as 3 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEMS WERE DIRTY AFTER STERILIZATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE ISSUE WAS NOTED DURING SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE SPOTLIGHT ACCESS SYSTEM 40 DEGREES KERRISON RONGEUR 2MM. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18624648 ↗MalfunctionApr 15, 2020Break; Break
IT WAS REPORTED THAT ON (B)(6) 2020 THE SPOTLIGHT 2MM KERRISON RONGEUR WAS BROKEN DURING A REVERSE LOGISTICS AUDIT OF RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) SPOT 2MM KERRISON RONGUER, 40. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9962195 ↗MalfunctionOct 30, 2019Break; Break
LIBERTAS: IT WAS REPORTED THAT ON (B)(6) 2019, THE (1) SPOTLIGHT 2MM KERRISON RONGEUR AND (1) UNIVERSAL NAVIGATION ADAPTOR HAS FAILED DURING THE CALIBRATION DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9255386 ↗
Other RONGEUR devices
- SPOTLIGHT 292904201Depuy Spine, LLC · RONGEUR6 reports
- Symmetry RapidClean® 58-3200J-BDAspen Surgical Products, Inc. · Rongeur5 reports
- SPOTLIGHT 292904202Medos International Sàrl · RONGEUR5 reports
- NA 03.605.001Synthes GmbH · RONGEUR4 reports
- Symmetry Rapidclean® 58-3200-BDAspen Surgical Products, Inc. · Rongeur3 reports
- Medicon 57.28.33Medicon eG. Chirurgiemechaniker-Genossenschaft · RONGEUR3 reports
- AESCULAP FF805RAesculap AG · RONGEUR3 reports
- Integra® Jarit® 280405Integra Lifesciences Production Corporation · RONGEUR3 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page