NA 7205325Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010251534), received between Sep 21, 2017 and Aug 25, 2020 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BLADE WAS SHOWING METAL DEBRIS IN THE JOINT WHEN IT IS USED AND RUBBING ON THE INSIDE SHAFT OF THE BLADE; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH LESS THAN 30 MINUTES DELAY USING A BACK-UP 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 Known Impact Or Consequence To Patient

  MAUDE report 10448645 ↗
• InjuryAug 24, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BLADE WAS SHOWING METAL DEBRIS IN THE JOINT WHEN IT IS USED AND RUBBING ON THE INSIDE SHAFT OF THE BLADE; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH LESS THAN 30 MINUTES DELAY USING A BACK-UP 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10445601 ↗
• InjuryAug 24, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BLADE WAS SHOWING METAL DEBRIS IN THE JOINT WHEN IT IS USED AND RUBBING ON THE INSIDE SHAFT OF THE BLADE; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH LESS THAN 30 MINUTES DELAY USING A BACK-UP DEVICE. NO 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 Known Impact Or Consequence To Patient

  MAUDE report 10445538 ↗
• InjuryAug 24, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BLADE WAS SHOWING METAL DEBRIS IN THE JOINT WHEN IT IS USED AND RUBBING ON THE INSIDE SHAFT OF THE BLADE; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH LESS THAN 30 MINUTES DELAY USING A BACK-UP DEVICE. NO 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 Known Impact Or Consequence To Patient

  MAUDE report 10445485 ↗
• InjuryAug 18, 2020Flaked; Material Fragmentation; Flaked; Material Fragmentation

  IT WAS REPORTED THAT DURING HIP ARTHROSCOPY PROCEDURE, THE BLADE WAS SHOWING METAL DEBRIS IN THE JOINT WHEN IT IS USED AND RUBBING ON THE INSIDE SHAFT OF THE BLADE. IT IS UNKNOWN IF THERE WAS A DELAY AND HOW THE PROCEDURE WAS COMPLETED. NO 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 Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10423592 ↗
• InjuryAug 18, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING HIP ARTHROSCOPY PROCEDURE, THE BLADE WAS SHOWING METAL DEBRIS IN THE JOINT WHEN IT IS USED AND RUBBING ON THE INSIDE SHAFT OF THE BLADE. IT IS UNKNOWN IF THERE WAS A DELAY AND HOW THE PROCEDURE WAS COMPLETED. NO 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 10423588 ↗
• InjuryAug 18, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING HIP ARTHROSCOPY PROCEDURE, THE BLADE WAS SHOWING METAL DEBRIS IN THE JOINT WHEN IT IS USED AND RUBBING ON THE INSIDE SHAFT OF THE BLADE. IT IS UNKNOWN IF THERE WAS A DELAY AND HOW THE PROCEDURE WAS COMPLETED. NO 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 10423582 ↗
• InjuryAug 18, 2020Flaked; Material Fragmentation; Flaked; Material Fragmentation

  IT WAS REPORTED THAT DURING HIP ARTHROSCOPY PROCEDURE, THE BLADE WAS SHOWING METAL DEBRIS IN THE JOINT WHEN IT IS USED AND RUBBING ON THE INSIDE SHAFT OF THE BLADE. IT IS UNKNOWN IF THERE WAS A DELAY AND HOW THE PROCEDURE WAS COMPLETED. NO 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 Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10423541 ↗
• MalfunctionNov 28, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE THE BLADE WAS BEING USED IN THE PATIENT, PLASTIC SHAVINGS OF THE CONNECTOR FELL OFF INTO THE JOINT. THE PLASTIC SHAVINGS WERE TRIED TO BE REMOVED BY FORCEPS, BUT COULD NOT COMPLETELY BE TAKEN OUT FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9390505 ↗
• MalfunctionFeb 13, 2018Peeled/Delaminated

  IT WAS REPORTED THAT THE DEVICE IS SHEDDING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7268058 ↗
• MalfunctionSep 21, 2017Metal Shedding Debris

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE BURR WAS SHEDDING, SUCTION WAS USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6883871 ↗