NA 7210979Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010544001), received between Sep 22, 2019 and Aug 14, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, METAL CAME OFF THE BLADE 4.5 BONECUTTER. SURGERY WAS COMPLETED USING 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 22802282 ↗
• MalfunctionAug 13, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY; AFTER USING ONE (1) 4.5 FULL RADIUS BONECUTTER, METAL SHAVINGS WERE FOUND WITHIN THE JOINT. ALL THE METAL SHAVINGS WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A DELAY LESS THAN OR EQUAL TO 30 MINUTES, WITH A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801189 ↗
• MalfunctionAug 4, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, RIGHT AFTER RUNNING THE BONECUTTER BLADE, BEFORE MAKING CONTACT WITH ANY SOFT TISSUE OR BONE, METAL SHAVINGS WERE OBSERVED IN THE JOINT SPACE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT WAS NOT INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710651 ↗
• MalfunctionJun 3, 2025Material Fragmentation; Material Twisted/Bent; Physical Resistance/Sticking; Material Fragmentation; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BONECUTTER BLADE HAD METAL SHAVINGS/DEBRIS. ALL THE SHRED MATERIAL WAS REMOVED FROM THE PATIENT WITH OSCILLATION MODE IN THE SHAVER. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY OF 1-5 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22135348 ↗
• MalfunctionMay 21, 2025Material Fragmentation; Material Twisted/Bent; Physical Resistance/Sticking; Material Fragmentation; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE A BLADE BONECUTTER HAD METAL SHAVINGS/DEBRIS. ALL THE SHRED MATERIAL WAS REMOVED FROM THE PATIENT WITH OSCILLATION MODE IN THE SHAVER. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY OF 1-5 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067344 ↗
• InjurySep 25, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A LEFT HIP ARTHROSCOPY WITH GLUTEUS MEDIUS REPAIR SURGERY, THE BONECUTTER WAS LOCKED AND STARTED OVERHEATING. THE PHYSICIAN PLACED THE SHAVER IN THE PATIENT'S ABDOMEN. THEN POST-OP DRAPES WERE REMOVED AND A BURN COULD BE NOTICED ON THE ANTERIOR LATERAL ABDOMEN. THE WOUND WAS CLEANED AND DRESSED WITH SILVADENE, TELFA AND ADAPTIC. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. THE PATIENT WAS TRANSFERRED TO PACU. THE ABDOMINAL WOUND REQUIRED RESECTION REPAIR AND IS HEALING WELL. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Burn(s)

  MAUDE report 10590245 ↗
• MalfunctionMar 20, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE BLADE RELEASED PARTICLES. NO PATIENT INJURIES OR DELAY REPORTED. IT IS UNKNOWN IF THERE WAS BACKUP DEVICE AVAILABLE. 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 9861391 ↗
• MalfunctionOct 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE SHAVER BLADE LOOSED PARTS AND BROKE INSIDE THE PATIENT. IT WAS RECEIVED ADDITIONAL INFORMATION STATING THAT THIS HAPPENED IN THE 4TH TIME, NOT IN 4 DIFFERENT CASES. THE PIECES WERE REMOVED FROM THE PATIENT AND THERE WAS NO DELAY OR PATIENT INJURIES REPORTED BUT IT IS UNKNOWN IF A BACKUP WAS AVAILABLE TO COMPLETE THE PROCEDURE. ATTEMPTS WERE MADE TO RETRIEVE FURTHER DETAILS ABOUT THE EVENT BUT THE COMPLAINANT DOES NOT HAVE MORE INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9142703 ↗
• MalfunctionSep 22, 2019Flaked; Flaked

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE DEVICE WAS RELEASING CUTLER (LOOSENING LINT). NO BACK UP DEVICE WAS AVAILABLE AND NO DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9102249 ↗