NA 03.605.002Recalls & reported problems
Synthes GmbH · DISC RONGEUR STRAIGHT WITHOUT TEETH 6MM WIDTH 330MM · Class 1
Data updated Oct 16, 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 10705034712345), received between Jun 28, 2022 and Jun 28, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem1
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.
MalfunctionJun 28, 2022Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 A COMPLAINT RECEIVED AGAINST DISC RONGEUR STRAIGHT WITHOUT TEETH 6MM THAT THE INSTRUMENT WAS BROKEN. CURRENTLY DO NOT HAVE THE INSTRUMENT IN MY POSSESSION, IT IS EXPECTED THIS WEEK IN WEST CHESTER. IF PROVIDE HIM WITH A SHIPPING ADDRESS HE CAN SEND IT OUT TO YOU FOR EVALUATION. THERE WAS A PATIENT INVOLVEMENT. DEVICE IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION AVAILABLE. THIS COMPLAINT INVOLVES ONE(1) DEVICE DISC RONGEUR STRAIGHT WITHOUT TEETH 6MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14841014 ↗
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
- Medicon 57.28.33Medicon eG. Chirurgiemechaniker-Genossenschaft · RONGEUR3 reports
- AESCULAP FF805RAesculap AG · RONGEUR3 reports
- Symmetry Rapidclean® 58-3200-BDAspen Surgical Products, Inc. · 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 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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