NA 7205307Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010251350), received between Jun 19, 2018 and Nov 7, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Flaked” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE FULL RADIUS BLADE WAS RELEASING UNUSUALLY LARGE SILVER PARTICLES PRODUCED BY FRICTION. ACCORDING TO THE PICTURE PROVIDED, IT HAPPENED INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500836 ↗
• MalfunctionOct 1, 2024Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE FULL RADIUS BLADE WAS CATCHING ON THE BARREL, EFFECTIVELY SHAVING ITSELF, LEAVING SMALL SHARDS OF METAL INSIDE THE PATIENT'S KNEE. ALL FRAGMENTS WERE EASILY REMOVED USING ANOTHER SHAVER BLADE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349486 ↗
• InjuryNov 22, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE PHYSICIAN VISUALIZED METALLIC FRAGMENTS IN THE PATIENT'S CAVITY (AS POWDER) AT THE TIME OF USING THE FULL RADIUS BLADE. THE FRAGMENTS WERE REMOVED FROM THE PATIENT WITH THE SUCTION OF THE PUMP. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15843455 ↗
• InjuryOct 22, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, METALLIC FRAGMENTS OF THE FULL RADIUS BLADE WERE OBSERVED COMING OUT OF THE PRODUCT. THE DOCTOR REMOVED EVERYTHING AND THE SURGERY WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656180 ↗
• InjuryJun 9, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE FULL RADIUS BLADE WAS SHEDDING FRAGMENTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640593 ↗
• InjuryFeb 17, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, SMALL METALLIC FRAGMENTS WERE OBSERVED THAT COULD HAVE COME OUT OF THE 'BLADE' WHICH WAS THE ONLY METALLIC DEVICE USED AT THAT TIME BESIDES THE OPTICS. IT WAS CLEANED WITH GAUZE AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO SURGICAL DELAYS OR HARMS TO THE PATIENT WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549644 ↗
• MalfunctionJun 19, 2018Material Fragmentation

  IT WAS REPORTED THAT DURING THE SURGERY METAL BLADE FRAGMENTS WERE LOST IN THE PATIENT WHILE THE BONE WAS BEING SCRAPPED. NO PATIENT INJURY WAS REPORTED. BACK-UP DEVICE WAS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7616638 ↗