FMS 283609Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705027255), received between May 25, 2018 and Nov 13, 2020 — classified as 2 injuries, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SHAVER SYSTEM DEVICE HAD METAL ABRASIONS. THERE WERE FRAGMENTS GENERATED THAT REMAINED INSIDE THE PATIENT'S KNEE JOINT. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 10838599 ↗
• InjuryMay 30, 2018Material Fragmentation; Material Fragmentation

  I NEED TO ADVISE OF 2 BROKEN MITEK SHAVER BLADES THAT WERE USED IN THIS HOSPITAL ON FRIDAY LAST. THE LIST WAS LATE AFTERNOON, HENCE ONLY REPORTING TODAY ONE OF THE CODES IS 283609 FULL RADIUS BLADE PLUS LOT M1311033 - THIS BROKE OFF AT THE PLASTIC INTERFACE, THE OTHER CODE WAS 283609 FULL RADIUS BLADE PLUS, LOT M1610001 - THIS HAD METAL SHARDS COME OFF AND GO INTO THE JOINT. REMNANTS OF NEITHER OF THE ITEMS WAS RETAINED. I WILL COMPLETE THE FORM THIS EVENING, AND I CAN SUPPLY FURTHER DETAILS AND PHOTOS OF THE DAMAGED ITEMS. AFTER DISCUSSION WITH THE SURGEON IT TRANSPIRES THAT HE WAS USING THEM TO BURR BONE SO THIS MAY HAVE CONTRIBUTED TO THE PROBLEMS THIS COMPLAINT COVERS THE OTHER CODE WAS 283609 FULL RADIUS BLADE PLUS, LOT M1610001 - THIS HAD METAL SHARDS COME OFF AND GO INTO THE JOINT. FOLLOWING CONFIRMATION FROM THE SURGEON ON (B)(6) 2018: IT WAS HIGHLIGHTED TO YOU THAT THESE 2 DEVICES FAILED IN 2 SEPARATE SURGERIES. DUE TO THE DEVICE FAILING IN 2 SEPARATE CASES, WE ARE REQUIRED TO RAISE THIS AS 2 NEW COMPLAINTS. PC-(B)(4) COVERS: THE OTHER CODE WAS 283609 FULL RADIUS BLADE PLUS, LOT M1610001 - THIS HAD METAL SHARDS COME OFF AND GO INTO THE JOINT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7552917 ↗
• MalfunctionMay 25, 2018Break; Break

  I NEED TO ADVISE OF A BROKEN MITEK SHAVER BLADE THAT WAS USED IN THIS HOSPITAL ON FRIDAY LAST. THE LIST WAS LATE AFTERNOON, HENCE ONLY REPORTING TODAY REMNANTS OF NEITHER OF THE ITEMS WAS RETAINED. AFTER DISCUSSION WITH THE SURGEON IT TRANSPIRES THAT HE WAS USING THEM TO BURR BONE SO THIS MAY HAVE CONTRIBUTED TO THE PROBLEMS THIS COMPLAINT IS FOR ONE OF THE CODES IS (B)(4) FULL RADIUS BLADE PLUS LOT M1311033 - THIS BROKE OFF AT THE PLASTIC INTERFACE,

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7544047 ↗