FAST-FIX 014550Recalls & reported problems
Smith & Nephew, Inc. · DIAMOND RASP 90 DEGREE · Class 2
All models of FAST-FIX (18)
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 03596010096111), received between Mar 13, 2020 and Oct 4, 2022 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Flaked1
Patient problems
- Laceration(s)1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER AN ARTHROSCOPY USING A DIAMOND RASP, THE PATIENT EXPERIENCED A TWISTING INJURY TO THE RIGHT KNEE. A LARGE DISPLACED FRAGMENT OF LATERAL MENISCUS TEAR WAS NOTED ON MRI. THE PATIENT WAS TREATED BY CONSERVATIVE MANAGEMENT. THE ISSUE IS RESOLVING.
Patient problems: Laceration(s)
MAUDE report 15538601 ↗InjuryJan 4, 2021Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE TIP OF THE DIAMOND BROKE INSIDE THE PATIENTS JOINT, PIECES WERE REMOVED WITH THE SHAVER. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND A SIGNIFICANT DELAY WAS REPORTED. NO FURTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11113532 ↗MalfunctionMar 13, 2020Flaked; Flaked
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE DIAMOND RASP WAS LOSING SOME METALLIC DEBRIS /FLAKES INSIDE THE PATIENT'S JOINT. THE PARTICLES WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. THERE WAS AN AVAILABLE BACKUP DEVICE. NEITHER DELAY OR PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9832176 ↗
Other ARTHROSCOPE devices
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 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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