NA SMI7210499Recalls & reported problems
Sterilmed, Inc. · SHAVER BLADE FULL RADIUS ELITE MAROON · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888551034531), received between Apr 3, 2019 and Feb 20, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A (B)(6) OLD FEMALE PATIENT WITH A LEFT SHOULDER ROTATOR CUFF TEAR UNDERWENT A LEFT SIDED ARTHROSCOPY AND ARTHROSCOPY ASSISTED ROTATOR CUFF REPAIR WITH SUBACROMIAL DECOMPRESSION AND DISTAL CLAVICLE RESECTION WITH A REPROCESSED SHAVER BLADE FULL RADIUS ELITE MAROON. DURING THE PROCEDURE, TWO TINY PIECES OF METAL BROKE FREE FROM THE REPROCESSED SHAVER BLADE. THE JOINT WAS IRRIGATED PROFUSELY, AND THE METAL PIECES WASHED OUT OF THE JOINT INTO THE SUCTION COLLECTION. SHAVER WAS REMOVED AND REPLACED. THERE WAS NO INJURY TO PATIENT. IN ADDITION, THE PRODUCT WAS USED PAST ITS EXPIRATION DATE, 6/25/2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9734573 ↗MalfunctionApr 3, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A PIECE OF SURGICAL GLOVE WAS IN THE CLIPPER OF THE SHAVER BLADE FULL RADIUS ELITE MAROON INSIDE THE PACKAGING. PRODUCT WAS STILL SEALED, AND THE MATERIAL CAN BE VISIBLY SEEN THROUGH THE PLASTIC PACKAGING. THEREFORE, THE PRODUCT WAS NOT OPENED OR USED ON A PATIENT. THERE WAS NO PATIENT CONSEQUENCE. THIS EVENT HAS BEEN ASSESSED AS A REPORTABLE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8480367 ↗
Other ARTHROSCOPE devices
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- 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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