FMS 283709Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705022069), received between Oct 9, 2018 and Mar 31, 2026 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS A VERY THICK WHITE DEPOSIT PRESENT ON THE TIP OF THE FULL RADIUS 5.0MM SHAVER SYSTEM DEVICE. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742315 ↗
• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, AFTER USING THE FULL RADIUS 5.0MM 5PK DEVICE FOR DEBRIDEMENT, IT WAS DISCOVERED THAT THE BLADE CAUSED SCATTERING OF METAL DEBRIS. THE FAULTY DEVICE WAS SUBSEQUENTLY DISCARDED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561972 ↗
• MalfunctionMar 26, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SHOULDER SURGICAL PROCEDURE ON AN UNKNOWN DATE THE SHAVER HANDPIECE DEVICE BLADE HAD NOTICEABLE METAL SHAVINGS WHILE IN USE WITH THE FULL RADIUS DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980381 ↗
• MalfunctionApr 8, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THERE WERE METAL ABRASIONS ON THE FULL RADIUS 5.0MM BLADE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14050993 ↗
• MalfunctionApr 16, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE BLADE DEVICE HAD METAL SHAVINGS. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT´S BODY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11678349 ↗
• MalfunctionApr 12, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE SCOPE PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT METAL FLAKES WERE PRODUCED WHILE USING A 5 MM FULL RADIUS BLADE PLUS DEVICE. ALL METAL FLAKES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11651544 ↗
• MalfunctionMar 26, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE BLADE DEVICE HAD AN EXCESS OF METAL CHARGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11576541 ↗
• InjuryMar 18, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING A KNEE ARTHROSCOPY THE DEVICE PRODUCED MENTAL PARTICLES (DEBRIS OF THE SHAVER BLADE). THE PROCEDURE WAS COMPLETED WITH A SECOND DEVICE. THE AFFILIATE DID NOT REPORT ANY PATIENT HARM. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THAT FLAKES FROM THE BLADE (NON-IMPLANT GRADE) WERE RETAINED IN THE PATIENT AND THERE WAS A SURGICAL DELAY

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 8430039 ↗
• MalfunctionNov 8, 2018Peeled/Delaminated; Peeled/Delaminated

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SHOULDER REPAIR, IT WAS OBSERVED THAT TWO FULL RADIUS 5.0MM 5PK DEVICES HAD METAL ABRASION. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2018. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8051839 ↗
• MalfunctionNov 8, 2018Peeled/Delaminated; Peeled/Delaminated

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SHOULDER REPAIR, IT WAS OBSERVED THAT TWO FULL RADIUS 5.0MM 5PK DEVICES HAD METAL ABRASION. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2018. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8051833 ↗
• InjuryNov 2, 2018Peeled/Delaminated; Peeled/Delaminated

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT TWO FULL RADIUS 5.0MM 5PK DEVICES HAD METAL ABRASION. IT WAS REPORTED THAT THE DEVICE WAS REMOVED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8032620 ↗
• InjuryOct 9, 2018Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL EVENT INFORMATION RECEIVED ON 12/03/2018. IT WAS REPORTED BY AN AFFILIATE THAT THERE ARE NO DEVICES COMES BACK.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 7947439 ↗