FMS 283429Recalls & reported problems

Summary

The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 10886705022229), received between May 18, 2018 and Sep 10, 2026 — classified as 20 injuries, 118 malfunctions.

The most frequently reported specific device problem is “Break” (82 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 25 most recent of 138 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break; Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714010 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHEN THE ULTRA AGGRESSIVE PLUS 4.0MM SHAVER TIP WAS ATTACHED TO THE HANDPIECE DEVICE, IT WAS OBSERVED THAT THE INNER CYLINDER CAME OFF AND THE DEVICE WAS UNUSABLE. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS RESIDUE LEFT IN THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366631 ↗
• MalfunctionDec 18, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE ULTRA AGGRESSIVE PLUS 4.0MM 5PK DEVICE OUT OF THE BOX, THE SUCTION DID NOT WORK WITH THE SHAVER BLADE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838709 ↗
• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT AT THE BEGINNING OF AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE, JUST AFTER ACTIVATING THE ULTRA AGGRESSIVE PLUS 4.0MM SHAVER SYSTEM BLADE DEVICE, IT WAS OBSERVED THAT THERE WERE METAL DEBRIS FRAGMENTS GENERATED, AND THE SURGEON NEEDED TO WASH THE JOINT OUT. IT WAS REPORTED THAT THERE WAS A 10-MINUTE DELAY IN THE PROCEDURE DUE TO EVENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555428 ↗
• MalfunctionNov 12, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT AT THE OUTSET OF AN UNSPECIFIED SURGICAL PROCEDURE, TWO ULTRA AGGRESSIVE PLUS 4.0MM DEVICES WERE OPENED AND APPEARED CONTAMINATED WITH A WHITE SUBSTANCE RESEMBLING GLUE. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533429 ↗
• MalfunctionNov 12, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT AT THE OUTSET OF AN UNSPECIFIED SURGICAL PROCEDURE, TWO ULTRA AGGRESSIVE PLUS 4.0MM DEVICES WERE OPENED AND APPEARED CONTAMINATED WITH A WHITE SUBSTANCE RESEMBLING GLUE. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533424 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED THAT AT THE START OF AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, RESIDUAL METAL DEBRIS WAS OBSERVED ON THE ULTRA AGGRESSIVE PLUS 4.0MM DEVICE WHEN THE WHEELER BLADE WAS ACTIVATED. IT WAS REPORTED THAT FRAGMENTS WERE GENERATED. THE JOINT WAS WASHED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS FIVE-MINUTE DELAY TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486329 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE, JUST AFTER ACTIVATING THE ULTRA AGGRESSIVE PLUS 4.0MM SHAVER SYSTEM BLADE DEVICE, IT WAS OBSERVED THAT THERE WERE METAL DEBRIS FRAGMENTS GENERATED, AND THE SURGEON NEEDED TO WASH THE JOINT OUT. IT WAS REPORTED THAT THERE WAS A 10-MINUTE DELAY IN THE PROCEDURE DUE TO EVENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351934 ↗
• MalfunctionAug 5, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO AN ARTHROSCOPY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ULTRA AGGRESSIVE PLUS 4.0MM 5PK DEVICE LEAKED. THERE WAS A MILKY WHITE LUBRICANT INSIDE THE PLANER BLADE WHICH SOLIDIFIED AND FLOWED OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22717595 ↗
• MalfunctionJul 14, 2025Degraded; Degraded

  IT WAS REPORTED THAT WHILE USING THE ULTRA AGGRESSIVE PLUS DEVICE, IT WAS OBSERVED THAT THE TISSUES WERE NOT DEBRIDED. THE SUCTION AND LINER WERE CHECKED; THE LINER WAS CHANGED BUT IT REMAINED THE SAME. THE SHAVER WAS DISCONNECTED; THE CONSOLE WAS TURNED OFF AND RESTARTED TO VERIFY AGAIN. THE REVOLUTIONS WERE INCREASED TO 3000 BUT IT REMAINED THE SAME. THE SPECIALIST INDICATES THAT THE REFERENCE OF THE BLADED COULD NOT BE CHARGED. THE DEVICE WAS USED WITH THE FMS VUE II PUMP-SHAVER BOX. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495186 ↗
• MalfunctionJun 11, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE ULTRA AGGRESSIVE PLUS 4.0MM DEVICE HAD A FOREIGN SUBSTANCE IN THE PACKAGING (FMIP-INORGANIC). THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185452 ↗
• MalfunctionMar 3, 2025Break; Break

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY, IT WAS OBSERVED THAT THE VAPR S90 W/ HAND CONTROLS DEVICE GENERATED SPARKS AND THEN THE ULTRA AGGRESSIVE PLUS 4.0MM DEVICE WAS FOUND TO HAVE DEBRIS FALLING OFF. ANOTHER DEVICES WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21502748 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE THE ULTRA AGGRESSIVE PLUS 4.0MM 5PK DEVICE METAL SHAVINGS FELL OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375645 ↗
• MalfunctionJan 23, 2025Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THERE WERE METAL DEBRIS FROM THE DEVICE SHORTLY AFTER THE PROCEDURE BEGAN. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218967 ↗
• MalfunctionJan 23, 2025Degraded; Degraded

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT DESPITE BEING A NEW ULTRA AGGRESSIVE PLUS 4.0MM 5PK DEVICE, IT FAILED TO CUT THE TISSUE. THE REVOLUTIONS INCREASED, BUT IT STILL DID NOT PERFORM ADEQUATELY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218687 ↗
• MalfunctionDec 27, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED FROM BELGIUM THAT THE ULTRA AGGRESSIVE PLUS 4.0MM SHAVER BLADE DEVICE HAD EXCESSIVE LUBRICANT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028743 ↗
• MalfunctionDec 5, 2024Degraded; Use of Device Problem; Degraded; Use of Device Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE ULTRA AGGRESSIVE PLUS 4.0MM DEVICE WHEN CONNECTING THE SHAVER HANDPIECE, DIDN'T WORK. THE HANDPIECE WAS CHANGED AND IT WORKED. WHEN OPENING THE SHAVER BLADE, AT THE TIME OF TURNING ON THE SHAVER TO WORK, THE INSIDE OF THE BLADE WOULD COME DOWN AND NOT CUT, DID NOT DO THE FUNCTION AS IT SHOULD. ANOTHER ONE WAS OPENED IT, CHECKED IF THERE WAS ANY PROBLEM AND NOTHING WAS FOUND. IT SNAPPED UP AGAIN AND EVEN THOUGH IT WAS GOING DOWN. SO WE OPENED ANOTHER BLADE AND IT WORKED THE RIGHT WAY. IT IS UNKNOWN WHETHER ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THE DEVICE WAS BEING USED WITH AN UNKNOWN SHAVER HANDPIECE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853212 ↗
• MalfunctionNov 11, 2024Break; Break

  REPORT 5 OF 5 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, METAL SHAVINGS FELL OFF THE ULTRA AGGRESSIVE PLUS 4.0MM 5PK DEVICE. ACCORDING TO THE REPORTER THE FIVE DEVICES IN THE SAME PACKAGE ALL HAD THE SAME PROBLEM. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651515 ↗
• MalfunctionNov 11, 2024Break; Break

  REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, METAL SHAVINGS FELL OFF THE ULTRA AGGRESSIVE PLUS 4.0MM 5PK DEVICE. ACCORDING TO THE REPORTER THE FIVE DEVICES IN THE SAME PACKAGE ALL HAD THE SAME PROBLEM. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651512 ↗
• MalfunctionNov 11, 2024Break; Break

  REPORT 3 OF 5 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, METAL SHAVINGS FELL OFF THE ULTRA AGGRESSIVE PLUS 4.0MM 5PK DEVICE. ACCORDING TO THE REPORTER THE FIVE DEVICES IN THE SAME PACKAGE ALL HAD THE SAME PROBLEM. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651504 ↗
• MalfunctionNov 11, 2024Break; Break

  REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, METAL SHAVINGS FELL OFF THE ULTRA AGGRESSIVE PLUS 4.0MM 5PK DEVICE. ACCORDING TO THE REPORTER THE FIVE DEVICES IN THE SAME PACKAGE ALL HAD THE SAME PROBLEM. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651503 ↗
• MalfunctionNov 11, 2024Break; Break

  REPORT 1 OF 5 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, METAL SHAVINGS FELL OFF THE ULTRA AGGRESSIVE PLUS 4.0MM 5PK DEVICE. ACCORDING TO THE REPORTER THE FIVE DEVICES IN THE SAME PACKAGE ALL HAD THE SAME PROBLEM. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651502 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED FROM THE NETHERLANDS THAT DURING A KNEE ARTHROSCOPY SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE ULTRA AGGRESSIVE PLUS 4.0MM SHAVER-BLADE WAS ACTIVATED INSIDE THE JOINT, METAL DEBRIS WAS SEEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20602061 ↗
• MalfunctionOct 4, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED FROM FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE APPEARANCE OF A SLIGHTLY LIQUID WHITE POWDER WAS SEEN WHEN OPENING (5) OMNICUT 5.2 RES BLADE, (4) ULTRA AGGRESSIVE PLUS 4.0MM, (13) ULTRA AGGRESSIVE PLUS 5.0. IT IS NOT CLEAR IF ALL (22) DEVICES WERE INVOLVED IN THE INCIDENT AND/OR IF THE USER EXPERIENCED THE SAME FAILURE FOR EACH DEVICE; THEREFORE, A REPORT WILL BE SUBMITTED FOR EACH DEVICE UNTIL FURTHER CLARIFICATION IS RECEIVED. THERE WERE NO SURGICAL DELAY OR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 7 OF 22 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20374775 ↗
• MalfunctionOct 4, 2024Device Contaminated During Manufacture or Shipping; Appropriate Device Problem Term/Code Not Available; Device Contaminated During Manufacture or Shipping; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE APPEARANCE OF A SLIGHTLY LIQUID WHITE POWDER WAS SEEN WHEN OPENING (5) OMNICUT 5.2 RES BLADE, (4) ULTRA AGGRESSIVE PLUS 4.0MM, (13) ULTRA AGGRESSIVE PLUS 5.0. IT IS NOT CLEAR IF ALL (22) DEVICES WERE INVOLVED IN THE INCIDENT AND/OR IF THE USER EXPERIENCED THE SAME FAILURE FOR EACH DEVICE; THEREFORE, A REPORT WILL BE SUBMITTED FOR EACH DEVICE UNTIL FURTHER CLARIFICATION IS RECEIVED. THERE WERE NO SURGICAL DELAYS OR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 19 OF 22 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372658 ↗