NA 7210499Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 03596010494764), received between Dec 4, 2017 and Apr 3, 2024 — classified as 6 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (9 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, PARTICLES WERE RELEASED INTO THE PATIENT'S JOINT, EVEN THOUGH THE DISPOSABLE BLADE DEVICE WAS NOT LOCKED. THERE WAS PRESENCE OF A FOREIGN BODY IN THE PATIENT'S BODY. IT IS POSSIBLE THAT ALL THE PARTICLES WERE REMOVED FROM THE PATIENT USING SUCTION. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A 20-MIN DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19033204 ↗
• MalfunctionFeb 19, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, AFTER 5 MINUTES OF USING THE ELITE BLADE, A METALLIC NOISE WAS HEARD, FOLLOWED BY THE EMISSION OF METALLIC FLAKES IN THE KNEE JOINT. THE DEVICE SEEMS TO HAVE SEIZED UP AND HAS BECOME UNUSABLE. THE METAL PARTICLES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18731432 ↗
• MalfunctionFeb 2, 2024Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE DISPOSABLE BLADE WAS LOCKED/BLOCKED AND HEAT UP. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631807 ↗
• InjuryJan 17, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE FULL RADIUS ELITE BLADE NO LONGER WORKED PROPERLY AND "FLAKES" WERE SEEN ON THE SCREEN. AN ARTHROSCOPIC LAVAGE WAS APPLIED IN THE SHOULDER, AND REMOVED AS MUCH OF THE FLAKE AS POSSIBLE, BUT RESIDUE WAS STILL PRESENT. THE PROCEDURE WAS COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18530643 ↗
• InjuryDec 28, 2023Flaked; Material Fragmentation; Flaked; Material Fragmentation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THERE WERE PRESENCE OF NUMEROUS METAL CHIPS WITH THE USE OF TWO DISPOSABLE BLADE ELITE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. THE SURGERY WAS DELAYED BUT IT IS UNKNOWN THE SPECIFIC INTERVAL OF DELAY. THE PATIENT´S KNEE WAS WASHOUT AND NO FURTHER COMPLICATIONS WERE REPORTED. THE SHREDDED MATERIAL WAS RETRIEVED FROM THE PATIENT WITH SUCTION/CLEANING, HOWEVER NOT ALL SHRED/FLAKED MATERIAL WERE RETRIEVED FROM THE PATIENT.

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

  MAUDE report 18416124 ↗
• MalfunctionOct 12, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY, THE DISPOSABLE BLADE TIP WAS BLOCKED LEAVING MICRO FRAGMENTS OF METAL IN THE JOINT, THE PIECES WERE REMOVED BY SUCTION. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927771 ↗
• MalfunctionFeb 3, 2021Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT DURING THE SURGERY THE INNER BLADE OF A DISPOSABLE BLADE 4.5MM FR ELITE COULD NOT BE ROTATED WHEN IT WAS USED AND THIS CAUSED THE HANDPIECE TO GET HOT. THERE WAS NO PROBLEM WITH THE HANDPIECE BECAUSE OVERHEATING DID NOT OCCUR WHEN ANOTHER BLADES WERE CONNECTED TO IT AND USED. SURGERY WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT INJURIES OR DELAY REPORTED. 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 11271714 ↗
• InjuryNov 19, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING ARTHROSCOPIC SHOULDER SURGERY, THE SURGEON WAS COMPLAINING OF SHEDDING ON THE SHAVER BLADE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO OTHER COMPLICATIONS WERE REPORTED. MINOR DELAY TO CLEAR METAL SHAVINGS FROM JOINT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10871861 ↗
• InjuryNov 19, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING ARTHROSCOPIC SHOULDER SURGERY, THE SURGEON WAS COMPLAINING OF SHEDDING ON THE SHAVER BLADE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO OTHER COMPLICATIONS WERE REPORTED. MINOR DELAY TO CLEAR METAL SHAVINGS FROM JOINT. 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; No Information

  MAUDE report 10871765 ↗
• MalfunctionNov 19, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING ARTHROSCOPIC SHOULDER SURGERY, THE SURGEON WAS COMPLAINING OF SHEDDING ON THE SHAVER BLADE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO OTHER COMPLICATIONS WERE REPORTED. MINOR DELAY TO CLEAR METAL SHAVINGS FROM JOINT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10871710 ↗
• MalfunctionNov 19, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING ARTHROSCOPIC SHOULDER SURGERY, THE SURGEON WAS COMPLAINING OF SHEDDING ON THE SHAVER BLADE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO OTHER COMPLICATIONS WERE REPORTED. MINOR DELAY TO CLEAR METAL SHAVINGS FROM JOINT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10871705 ↗
• InjurySep 14, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE DISPOSABLE SHAVER WAS SHEDDING IN THE JOINT LEAVING METAL DEBRIS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10532673 ↗
• MalfunctionSep 10, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABEL OF THE BOX HAD A PROBLEM. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10518187 ↗
• MalfunctionSep 10, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABEL OF THE BOX HAD A PROBLEM. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10518155 ↗
• MalfunctionSep 10, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABEL OF THE BOX HAD A PROBLEM. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10518147 ↗
• MalfunctionSep 10, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABEL OF THE BOX HAD A PROBLEM. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10518145 ↗
• MalfunctionSep 10, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABEL OF THE BOX HAD A PROBLEM. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10518103 ↗
• MalfunctionSep 10, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABEL OF THE BOX HAD A PROBLEM. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10517934 ↗
• MalfunctionSep 10, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABEL OF THE BOX HAD A PROBLEM. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10517927 ↗
• MalfunctionSep 10, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABEL OF THE BOX HAD A PROBLEM. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10517870 ↗
• MalfunctionSep 10, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE LABEL OF THE BOX HAD A PROBLEM. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10517835 ↗
• MalfunctionFeb 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN LS ARTHROSCOPIC ROTATOR CUFF PROCEDURE, TWO TINY PIECES OF METAL BROKE FREE FROM THE REPROCESSED SHAVER BLADE. THE JOINT WAS IRRIGATED PROFUSELY AND THE METAL PIECES WASHED OUT OF THE JOINT INTO THE SUCTION COLLECTION. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. SURGICAL DELAY OR PATIENT INJURIES WERE NOT REPORTED. 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 9734292 ↗
• MalfunctionDec 4, 2017Metal Shedding Debris

  IT WAS REPORTED THAT THE BLADE WAS SHEDDING. ALL DEBRIS WAS REMOVED WITH SUCTION. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH A SHORT DELAY. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7079022 ↗