FMS 283729Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10886705022083), received between May 4, 2018 and Oct 14, 2024 — classified as 9 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (17 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2024Break; Break

  IT WAS REPORTED FROM SWEDEN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE ULTRA AGGRESSIVE PLUS 5.0 5PK DEVICE HAD METAL FRAGMENTS THAT WERE GENERATED FROM WHAT ONE SUSPECTS FROM THE SHAVER BLADE. IT IS NOT KNOWN IF 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 20443933 ↗
• 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 16 OF 22 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20378066 ↗
• MalfunctionOct 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 3 OF 22 FOR THE SAME EVENT IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372636 ↗
• 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 18 OF 22 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372595 ↗
• 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 6 OF 22 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372540 ↗
• 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 21 OF 22 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372506 ↗
• 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 10 OF 22 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372481 ↗
• 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 22 OF 22 FOR(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372415 ↗
• 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 20 OF 22 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372391 ↗
• 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 15 OF 22 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372335 ↗
• 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 4 OF 22 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372323 ↗
• 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 9 OF 22 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372186 ↗
• 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 8 OF 22 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372130 ↗
• 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 12 OF 22 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372127 ↗
• MalfunctionJul 16, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED FROM THE UNITED KINGDOM THAT WHILE THE SCRUB NURSE WAS SETTING UP FOR AN UNKNOWN SURGERY, ONE OF THE TORNADO SHAVERS FROM THE ULTRA AGGRESSIVE PLUS 5.0 5PK DEVICE WAS FOUND TO HAVE A DIRTY TIP. THE DEVICE WAS REMOVED IMMEDIATELY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19755919 ↗
• MalfunctionMay 3, 2024Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT TWO ULTRA AGGRESSIVE PLUS 5.0 DEVICES HAD METAL FLAKES DURING USE. 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 19241812 ↗
• MalfunctionMay 3, 2024Break; Break

  THIS IS REPORT 2 OF 2 (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT TWO ULTRA AGGRESSIVE PLUS 5.0 DEVICES HAD METAL FLAKES DURING USE. 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 19241788 ↗
• MalfunctionAug 23, 2023Break; Break

  IT WAS REPORTED BY THE DISTRIBUTOR IN BRAZIL THAT DURING AN UNKNOWN PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE 5 MM ULTRA AGGRESSIVE PLUS DEVICE BEGAN TO RELEASE METAL PARTICLES WHILE IN USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 17605644 ↗
• MalfunctionApr 26, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN FRANCE THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THERE WAS A PRESENCE OF A BIG QUANTITY OF WHITE LIQUID (LUBRICANT) INSIDE THE PACKAGING OF THE 5 MM ULTRA AGGRESSIVE PLUS DEVICE. ACCORDING TO THE REPORT, THE OPENED A SECOND ONE BUT IT HAD THE SAME ISSUE. IT WAS FURTHER REPORTED THAT THEY OPENED A THIRD ONE BUT NO MORE PRESENCE OF WHITE LIQUID IN SUCH AN IMPORTANT WAY. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 16816320 ↗
• MalfunctionApr 26, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN FRANCE THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THERE WAS A PRESENCE OF A BIG QUANTITY OF WHITE LIQUID (LUBRICANT) INSIDE THE PACKAGING OF THE 5 MM ULTRA AGGRESSIVE PLUS DEVICE. ACCORDING TO THE REPORT, THE OPENED A SECOND ONE BUT IT HAD THE SAME ISSUE. IT WAS FURTHER REPORTED THAT THEY OPENED A THIRD ONE BUT NO MORE PRESENCE OF WHITE LIQUID IN SUCH AN IMPORTANT WAY. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 16816314 ↗
• MalfunctionApr 26, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN FRANCE THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THERE WAS A PRESENCE OF A BIG QUANTITY OF WHITE LIQUID (LUBRICANT) INSIDE THE PACKAGING OF THE 5 MM ULTRA AGGRESSIVE PLUS DEVICE. ACCORDING TO THE REPORT, THE OPENED A SECOND ONE BUT IT HAD THE SAME ISSUE. IT WAS FURTHER REPORTED THAT THEY OPENED A THIRD ONE BUT NO MORE PRESENCE OF WHITE LIQUID IN SUCH AN IMPORTANT WAY. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 16816313 ↗
• MalfunctionJan 16, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN FRANCE THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THERE WERE METALLIC FLAKES SCATTERED INTO THE PATIENT'S KNEE WHILE USING THE 5 MM ULTRA AGGRESSIVE PLUS DEVICE. ACCORDING TO THE REPORT, THERE WAS AN ABUNDANT WASHOUT WITH SALINE TO REMOVE METAL DEBRIS IN THE PATIENT'S KNEE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. 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 16179051 ↗
• MalfunctionDec 23, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN BRAZIL THAT DURING AN UNKNOWN PROCEDURE OF THE KNEE ON (B)(6) 2022, IT WAS OBSERVED THAT AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 5 MM ULTRA AGGRESSIVE PLUS BLADE DEVICE RELEASED METAL FRAGMENTS INSIDE THE PATIENT'S KNEE. ACCORDING TO THE REPORT, THE SURGEON WASHED THE SITE BUT NOT EVERY FRAGMENT WAS REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16045187 ↗
• MalfunctionJul 29, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT A HAIR WAS INSIDE THE PACKAGING OF THE 5 MM ULTRA AGGRESSIVE PLUS DEVICE UPON OPENING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 15133678 ↗
• MalfunctionJul 5, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN AUSTRIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THERE WERE BLACK LITTLE PIECES CAME OFF THE 5 MM ULTRA AGGRESSIVE PLUS BLADE DEVICE. ALL THE FRAGMENTS WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED WIT NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14916736 ↗