NA 72203521Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00885554024333), received between Aug 16, 2019 and Apr 23, 2025 — classified as 29 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Flaked” (29 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON HIT THE SUTURE WITH THE FULL RADIUS BLADE AND THE TIP FRACTURED OFF INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893183 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE SURGEON HIT THE SUTURE WITH THE FULL RADIUS BLADE AND THE TIP FRACTURED OFF INSIDE THE PATIENT. IT IS UNKNOWN IF ALL THE PIECES WERE REMOVED FORM THE PATIENT. THE BLADE WAS PLACED DOWN AFTER USAGE, AND UPON IT BEING PICKED UP TO BE USED AGAIN IT WAS DISCOVERED THAT IT HAD BROKEN OFF. THE USER WAS UNABLE TO FIND EVIDENCE OF IT IN THE ROOM OR IN THE PATIENT. X-RAYS WERE PERFORMED TO ATTEMPT TO IDENTIFY IT IF IT WAS STILL IN THE PATIENT BUT IT WAS NOT SEEN ON IMAGING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21759340 ↗
• InjuryNov 7, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A KNEE SCOPE, THE BLADE WAS LEAVING A METAL MATERIAL IN THE JOINT. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20627433 ↗
• MalfunctionOct 14, 2024Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE PLATINUM BLADE WAS LEAVING METAL DEBRIS IN THE KNEE JOINT. 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 20445040 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT THE KNIFE OF THE FULL RADIUS BLADE BROKE IN TWO. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY, IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159475 ↗
• InjurySep 29, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE FULL RADIUS PLATINUM SERIES BLADE WAS LEAVING A BLACK RESIDUE ON THE FEMORAL CONDYLE THAT LOOKED LIKE METAL DEBRIS AND WAS NOT POSSIBLE TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12550764 ↗
• InjuryAug 13, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, INSIDE THE PATIENT, THE 4.5MM FULL RADIUS PLATINUM SERIES WAS LEAVING MARKS ON PATIENT'S TISSUE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12317948 ↗
• InjuryJun 15, 2021Flaked; Noise, Audible; Flaked; Noise, Audible

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, WHEN INTRODUCING THE FULL RADIUS PLATINUM BLADE INTO THE JOINT SPACE, A DARK POWDERY SUBSTANCE WAS LEFT ON THE SOFT TISSUE IT CAME IN CONTACT WITH. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE, NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 11999233 ↗
• InjuryJun 15, 2021Flaked; Noise, Audible; Flaked; Noise, Audible

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, WHEN INTRODUCING THE FULL RADIUS PLATINUM BLADE INTO THE JOINT SPACE, A DARK POWDERY SUBSTANCE WAS LEFT ON THE SOFT TISSUE IT CAME IN CONTACT WITH. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE, NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 11999214 ↗
• InjuryApr 23, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE , FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11718553 ↗
• InjuryApr 21, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE , FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703889 ↗
• InjuryApr 21, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE , FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703887 ↗
• InjuryApr 21, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE , FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703873 ↗
• InjuryApr 21, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE , FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703866 ↗
• InjuryApr 21, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE , FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703829 ↗
• InjuryApr 21, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE , FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703825 ↗
• InjuryApr 21, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE , FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698622 ↗
• InjuryApr 21, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE, FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698614 ↗
• InjuryApr 21, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE , FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698612 ↗
• InjuryApr 21, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE , FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698611 ↗
• InjuryApr 21, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE , FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698609 ↗
• InjuryApr 21, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE , FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698608 ↗
• InjuryApr 21, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE , FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698605 ↗
• InjuryApr 21, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE, FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698591 ↗
• InjuryApr 21, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING THE SURGERY WHEN THE SHAVER WAS BEING USE, METAL SHAVINGS WERE FOUND IN THE KNEE JOINT WHEN OSCILLATE , FORWARD AND REVERSE MODE WAS BEING USED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698580 ↗