NA 72202530Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 03596010655684), received between Dec 28, 2017 and Jun 13, 2026 — classified as 6 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (39 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A PROCEDURE, A FULL RADIUS BONECUTTER WAS SPITTING METAL FLAKES IMMEDIATELY WHEN IN USE. THE SHAVINGS WERE RESECTED OUT FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25495862 ↗
• MalfunctionJun 13, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A PROCEDURE, A FULL RADIUS BONECUTTER WAS SPITTING METAL FLAKES IMMEDIATELY WHEN IN USE. THE SHAVINGS WERE RESECTED OUT FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25495854 ↗
• MalfunctionJun 12, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A PROCEDURE, A FULL RADIUS BONECUTTER WAS SPITTING METAL FLAKES IMMEDIATELY WHEN IN USE. THE SHAVINGS WERE RESECTED OUT FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494282 ↗
• MalfunctionJun 10, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A PROCEDURE, A FULL RADIUS BONECUTTER WAS SPITTING METAL FLAKES IMMEDIATELY WHEN IN USE. THE SHAVINGS WERE RESECTED OUT FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25465708 ↗
• MalfunctionJun 8, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A PROCEDURE, A FULL RADIUS BONECUTTER WAS SPITTING METAL FLAKES IMMEDIATELY WHEN IN USE. THE SHAVINGS WERE RESECTED OUT FROM THE PATIENT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25426726 ↗
• MalfunctionJun 8, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A PROCEDURE, A FULL RADIUS BONECUTTER WAS SPITTING METAL FLAKES IMMEDIATELY WHEN IN USE. THE SHAVINGS WERE RESECTED OUT FROM THE PATIENT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25426656 ↗
• MalfunctionJun 6, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A PROCEDURE, A FULL RADIUS BONECUTTER WAS SPITTING METAL FLAKES IMMEDIATELY WHEN IN USE. THE SHAVINGS WERE RESECTED OUT FROM THE PATIENT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25419463 ↗
• MalfunctionJun 6, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A PROCEDURE, A FULL RADIUS BONECUTTER WAS SPITTING METAL FLAKES IMMEDIATELY WHEN IN USE. THE SHAVINGS WERE RESECTED OUT FROM THE PATIENT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25419406 ↗
• MalfunctionMay 20, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A PROCEDURE, A FULL RADIUS BONECUTTER WAS GENERATING METAL DEBRIS. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231084 ↗
• InjuryMay 1, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, AS SOON AS A FULL RADIUS BONECUTTER WAS PLUGGED IN AND STARTED TO BE USED IN THE JOINT, A LOT OF METAL DEBRIS STARTED COMING FROM THE BLADE. THE BLADE WAS IMMEDIATELY REMOVED. METAL DEBRIS WAS IN SMALL PIECES ALL IN THE PATIENT, SOME WAS SUCTIONED OUT WITH A SHAVER AND OTHER PIECES WERE LEFT IN PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS GOOD.

  Patient problems: Foreign Body In Patient

  MAUDE report 25062178 ↗
• MalfunctionDec 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, TWO (B)(4) UNITS OF A FULL RADIUS BONECUTTER 5.5MM PLATINUM RELEASED METALLIC PARTICLES. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771343 ↗
• MalfunctionOct 20, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A SHOULDER SCOPE PROCEDURE, IT WAS NOTICED THAT METAL SHAVINGS WERE COMING OFF FROM THE FULL RADIUS BONECUTTER 5.5MM PLATINUM. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335590 ↗
• MalfunctionOct 20, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A SHOULDER SCOPE PROCEDURE, IT WAS NOTICED THAT METAL SHAVINGS WERE COMING OFF FROM TWO (2) UNITS OF A FULL RADIUS BONECUTTER 5.5MM PLATINUM ((B)(4)). THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335569 ↗
• MalfunctionAug 18, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY WHILE USED THE BONE CUTTER BLADE LEFT BEHIND A LOT OF METAL DEBRIS, THE SURGERY WAS COMPLETED WITH THE SAME DEVICE, THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825087 ↗
• MalfunctionJul 20, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE FULL RADIUS PLATINUM BONECUTTER 5.5MM HAD AN INSTANCE OF METAL DEBRIS. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552563 ↗
• MalfunctionJul 17, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE FULL RADIUS PLATINUM BONECUTTER 5.5MM HAD INSTANCE OF METAL DEBRIS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22537936 ↗
• MalfunctionJul 17, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE FULL RADIUS PLATINUM BONECUTTER 5.5MM HAD INSTANCE OF METAL DEBRIS. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22531646 ↗
• MalfunctionJul 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE FULL RADIUS PLATINUM BONECUTTER 5.5MM HAD METAL DEBRIS. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520697 ↗
• MalfunctionJul 14, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE FULL RADIUS PLATINUM BONECUTTER 5.5 MM HAD AN INSTANCE OF METAL DEBRIS. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491645 ↗
• MalfunctionJul 13, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE FULL RADIUS PLATINUM BONECUTTER 5.5MM HAD METAL DEBRIS. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491202 ↗
• MalfunctionJun 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, METAL DEBRIS FROM THE 5.5 MM BONECUTTER PLATINUM WAS COMING OFF INSIDE THE PATIENT¿S JOINT; IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323057 ↗
• MalfunctionJun 22, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BONECUTTER HAD SHAVING ISSUES. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY, IF THERE WAS PATIENT INVOLVEMENT, IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22304641 ↗
• MalfunctionJun 18, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, ONE (1) PLATINUM BONECUTTER DEVICES WAS DEFECTIVE, AS PIECES OF METAL WERE CRUMBLING. THE PIECES WERE RETRIEVED USING ASPIRATION. THERE WAS A BACK-UP DEVICE AVAILABLE AND THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288615 ↗
• MalfunctionJun 17, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, ONE (1) PLATINUM BONECUTTER DEVICES WAS DEFECTIVE, AS PIECES OF METAL WERE CRUMBLING. THE PIECES WERE RETRIEVED USING ASPIRATION. THERE WAS A BACK-UP DEVICE AVAILABLE AND THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22237779 ↗
• MalfunctionJun 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, ONE (1) PLATINUM BONECUTTER WAS DEFECTIVE, AS PIECES OF METAL WERE CRUMBLING. THE PIECES WERE RETRIEVED USING ASPIRATION. THERE WAS A BACK-UP DEVICE AVAILABLE AND THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167967 ↗