FMS 283439Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886705022038), received between Jan 3, 2019 and Dec 9, 2024 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Degraded; Degraded

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE 4.0MM MULTIBLADE PLUS COULD NOT CUT. ANOTHER DEVICE 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 20878440 ↗
• MalfunctionDec 6, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING A KNEE SURGERY ON (B)(6) 2023 WHEN THE SURGEON WAS SHIVERING THE TISSUE IN THE JOINT WITH THE SHAVER HANDPIECE 2.0 WITH BUTTONS DEVICE, A BLACK LIQUID CAME OUT OF THE SUCTION TUBING FROM THE SHAVER HANDPIECE DEVICE. IT WAS REPORTED THAT NOTHING WAS VISIBLE IN THE JOINT, ONLY IN THE SHAVER OUTFLOW TUBING AND THE SCRUB NURSE THOUGHT FIRST IT WAS OIL FROM THE SHAVER HANDPIECE DEVICE BUT THE LIQUID WAS NOT FLOATING ON THE WASTE BIN SO SHE WASN'T SURE WHAT IT WAS EXACTLY. THERE WAS A FOUR MINUTE 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 18275473 ↗
• MalfunctionJun 20, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2023, A 4 MM MULTI BLADE PLUS DEVICE WAS USED. ACCORDING TO THE REPORT, AS SOON AS THE SURGEON STARTED TO USE THE SHAVER BLADE IN THE KNEE JOINT IT BUILT A LOT OF METAL ABRASION SPLINTER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17163313 ↗
• MalfunctionApr 26, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A KNEE ARTHROSCOPY SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT A SMALL BLACK ¿THING¿ WAS IN THE PLASTIC PART OF THE PACKING OF THE BLADE DEVICE. 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 14211088 ↗
• InjuryMar 9, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THERE WERE METAL PARTS IN THE JOINT AFTER USING THE 4.0MM MULTIBLADE PLUS DEVICE. ACCORDING TO THE REPORT, THAT THE DEVICE CAUSED DAMAGED TO THE CARTILAGE. THE PROCEDURE WAS COMPLETED. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13711050 ↗
• MalfunctionJun 11, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 4 MM MULTI BLADE PLUS DEVICE HAD METAL PARTS IN THE KNEE. IT WAS REPORTED THAT THE SURGEON BELIEVED IT WAS FROM THE SHAVER AS IT WAS THE ONLY METAL THING HE USED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE FRAGMENTS SHOULD HAVE GONE OUT WITH THE WATER FLOW FROM THE ARTHROSCOPIC PUMP AND WITH SUCTION FROM THE SHAVER. THERE WERE NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986139 ↗
• InjuryDec 30, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT WAS METAL SPREADING FROM THE BLADE DEVICE WITHIN THE FIRST 4 SECONDS OF ACTIVATING THE SHAVER HANDPIECE. ANOTHER BLADE WAS USED TO COMPLETE THE PROCEDURE WITH A FIVE MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 11097607 ↗
• InjuryDec 30, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT WAS METAL SPREADING FROM THE BLADE DEVICE WITHIN THE FIRST 4 SECONDS OF ACTIVATING THE SHAVER HANDPIECE. ANOTHER BLADE WAS USED TO COMPLETE THE PROCEDURE WITH A FIVE MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 11097537 ↗
• InjuryDec 29, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A KNEE ARTHROSCOPY AND CARTILAGE DEBRIDEMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THERE WAS METAL SPREADING WHILE USING A 4 MM MULTI BLADE PLUS DEVICE. THE SURGEON HAD NO PRESSURE ON THE HANDPIECE. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. THERE WERE STILL SMALL PARTS OF THE DEVICE IN THE KNEE JOINT. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11088063 ↗
• InjuryDec 18, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE 4.0MM MULTIBLADE PLUS 5PK DEVICE HAD METAL ABRASION WHICH WERE NOT WITH THE FIRST "RANDOM" OF THE BLADE. FRAGMENTS WERE GENERATED AND COULD NOT BE RETRIEVED FROM THE PATIENT'S BODY. LAVAGE WAS PERFORMED. IT WAS REPORTED THAT THERE WAS A TWO MINUTE DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11037335 ↗
• MalfunctionDec 12, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE 4.0MM MULTIBLADE PLUS DEVICE WAS CLOGGED. IT WAS REPORTED THAT THERE WAS A LESS THAN ONE MINUTE DELAY IN THE PROCEDURE. IT WAS NOT REPORTED WHETHER A LIKE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10995328 ↗
• MalfunctionDec 8, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A KNEE ARTHROSCOPY PROCEDURE, IT WAS OBSERVED THAT THE 4.0 MM MULTIBLADE PLUS DEVICE SHAVER CLOGGED OFTEN. IT WAS REPORTED THAT THERE WAS A THREE MINUTE DELAY IN THE PROCEDURE AND ANOTHER LIKE DEVICE 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 10969562 ↗
• MalfunctionDec 8, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A KNEE ARTHROSCOPY PROCEDURE, IT WAS OBSERVED THAT THE 4.0 MM MULTIBLADE PLUS DEVICE SHAVER CLOGGED OFTEN. ANOTHER LIKE DEVICE 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 10969420 ↗
• MalfunctionDec 8, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A KNEE ARTHROSCOPY PROCEDURE, IT WAS OBSERVED THAT THE 4.0 MM MULTIBLADE PLUS DEVICE SHAVER CLOGGED OFTEN. ANOTHER LIKE DEVICE 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 10968834 ↗
• MalfunctionDec 8, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A KNEE ARTHROSCOPY PROCEDURE, IT WAS OBSERVED THAT THE 4.0 MM MULTIBLADE PLUS DEVICE SHAVER CLOGGED OFTEN. ANOTHER LIKE DEVICE 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 10968744 ↗
• MalfunctionJan 3, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THERE WERE SOME PROBLEMS WITH 4 MM MULTI BLADE PLUS. AFFILIATE STATED THAT THERE WERE METAL PARTICULATES IN JOINT FROM TORNADO SHAVER. IT WAS DISCOVERED DURING KNEE ARTHROSCOPY SURGICAL PROCEDURE. ALL PARTICULATES WERE REMOVED BY CHANGING THE BLADE WITHOUT ANY PATIENT HARM. THERE WAS A FIVE MINUTES SURGICAL DELAY. 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: No Consequences Or Impact To Patient

  MAUDE report 8212236 ↗