Medline ReNewal REP112994Recalls & reported problems
Medline Industries, Inc. · 72203013 PLATINUM, INCISORPLS BLADE, (S · Class 2
All models of Medline ReNewal (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888277354692), received between Nov 8, 2016 and Jun 2, 2021 — classified as 1 injury, 2 malfunctions.
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 18, 2026.
Most reported problems
Device problems
- Break1
- Material Integrity Problem1
- Physical Resistance/Sticking1
Patient problems
- Foreign Body In Patient1
- 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.
MalfunctionJun 2, 2021Break
IT WAS REPORTED, "ITEM BROKE INTO PIECES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11925151 ↗InjuryAug 18, 2020Physical Resistance/Sticking
IT WAS REPORTED THAT A DEVICE GOT STUCK IN THE PATIENT'S KNEE MID SURGERY AND REQUIRED REMOVAL. A NEW BLADE WAS OPENED TO FINISH THE PROCEDURE WITHOUT FURTHER INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 10421267 ↗MalfunctionNov 8, 2016Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A REPROCESSED DYONICS PLATINUM ARTHROSCOPIC SHAVER SNAPPED APART IN THE KNEE DURING USE. THE REPORT DID NOT INDICATE THAT THE DEVICE FAILURE RESULTED IN PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6088142 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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