FMS 283412Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886705025923), received between Sep 5, 2019 and Apr 24, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE OF THE KNEE, WHEN USING THE CRVD AGG BLADE 4.2MM DEVICE, IT WAS OBSERVED THAT THE DISTAL END OF THE SHAVER BLADE BROKE OFF. IT WAS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE, OR IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN MARCH OF 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982598 ↗
• MalfunctionFeb 8, 2026Premature Activation

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE, WHEN USING THE OMNISPAN MENISCAL REPAIR 27DEG ANCHOR DEVICE, IT WAS OBSERVED THAT AFTER THE 1ST FIRING, TWO PLATES WERE DEPLOYED AT THE SAME TIME. IT WAS REPORTED THAT 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 24288242 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE CRVD AGG BLADE 4.2MM 5PK DEVICE WAS BEING USED WHEN THE INNER PART OF THE BLADE (FLEXIBLE PART) BROKE. IT IS UNKNOWN WHETHER ANOTHER 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 24267475 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE CRVD AGG BLADE 4.2MM 5PK DEVICE WAS BEING USED WHEN THE INNER PART OF THE BLADE (FLEXIBLE PART) BROKE. IT IS UNKNOWN WHETHER ANOTHER 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 24267195 ↗
• MalfunctionDec 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE THE TIP OF THE CRVD AGG BLADE 4.2MM DEVICE FELL APART. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. 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 23726442 ↗
• MalfunctionNov 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, IT WAS OBSERVED THAT THE CRVD AGG BLADE 4.2MM 5PK DEVICE BROKE. 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 23580768 ↗
• MalfunctionNov 14, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE THREE (X3) CRVD AGG BLADE 4.2MM 5PK DEVICES WERE TAKEN FOR A SINGLE PATIENT AND THE BLADES JAMMED AND DID NOT FUNCTION. IT IS UNKNOWN WHETHER ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 3 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553459 ↗
• MalfunctionNov 14, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE THREE (X3) CRVD AGG BLADE 4.2MM 5PK DEVICES WERE TAKEN FOR A SINGLE PATIENT AND THE BLADES JAMMED AND DID NOT FUNCTION. IT IS UNKNOWN WHETHER ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 3 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553458 ↗
• MalfunctionNov 14, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE THREE (X3) CRVD AGG BLADE 4.2MM 5PK DEVICES WERE TAKEN FOR A SINGLE PATIENT AND THE BLADES JAMMED AND DID NOT FUNCTION. IT IS UNKNOWN WHETHER ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 3 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553456 ↗
• MalfunctionJan 28, 2025Packaging Problem; Packaging Problem

  THIS IS REPORT 3 OF 4 FOR (B)(4). IT WAS REPORTED THAT PREOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DESCRIPTION ON THE BOX OF AN UNKNOWN CUTTING INSTRUMENT DEVICE DID NOT MATCH THE CONTENT. ACCORDING TO THE REPORT, THE CUSTOMER ORDERED CURVED SHAVER BLADES. IT SAID ON THE BOX THAT THE BOX CONTAINED FIVE CURVED SHAVER BLADES BUT ONLY ONE WAS CURVED AND FOUR WERE NOT CURVED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN DECEMBER 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252919 ↗
• MalfunctionJan 28, 2025Packaging Problem; Packaging Problem

  THIS IS REPORT 4 OF 4 FOR (B)(4). IT WAS REPORTED THAT PREOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CONTENTS OF THE BOX DID NOT MATCH THE DESCRIPTION OF THE CRVD AGG BLADE 4.2MM 5PK DEVICE. ACCORDING TO THE REPORT, ONLY ONE OUT OF THE FIVE BLADES WAS CURVED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN (B)(6).2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252917 ↗
• MalfunctionJan 28, 2025Packaging Problem; Packaging Problem

  THIS IS REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED THAT PREOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CONTENTS OF THE BOX DID NOT MATCH THE DESCRIPTION OF THE CRVD AGG BLADE 4.2MM 5PK DEVICE. ACCORDING TO THE REPORT, ONLY ONE OUT OF THE FIVE BLADES WAS CURVED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN (B)(6) 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252911 ↗
• MalfunctionJan 24, 2025Packaging Problem; Packaging Problem

  THIS IS REPORT 1 OF 4 FOR (B)(4). IT WAS REPORTED THAT PREOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DESCRIPTION ON THE BOX OF AN UNKNOWN CUTTING INSTRUMENT DEVICE DID NOT MATCH THE CONTENT. ACCORDING TO THE REPORT, THE CUSTOMER ORDERED CURVED SHAVER BLADES. IT SAID ON THE BOX THAT THE BOX CONTAINED FIVE CURVED SHAVER BLADES BUT ONLY ONE WAS CURVED AND FOUR WERE NOT CURVED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN (B)(6) 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232816 ↗
• MalfunctionMar 20, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE ARTHROSCOPY WITH ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE PLASTIC SHEATH WAS BREAKING AND BUNCHING ON INNER BLADE ON THE FMS CURVED AGGRESSIVE BLADE PLUS 4.2MM DEVICE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITH A DELAY OF TWO MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16575424 ↗
• MalfunctionJul 23, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THERE WAS A RELEASE OF METALLIC DEPOSITS WHEN THE FMS CURVED AGGRESSIVE BLADE PLUS 4.2MM DEVICE WAS ACTIVATED. 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 12217215 ↗
• MalfunctionJul 23, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THERE WAS A RELEASE OF METALLIC DEPOSITS WHEN THE FMS CURVED AGGRESSIVE BLADE PLUS 4.2MM DEVICE WAS ACTIVATED. 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 12217214 ↗
• MalfunctionSep 5, 2019Break; Break

  THE SALES REP REPORTED VIA PHONE THAT THE INNER SHAFT OF THE CUSTOMER'S CURVED AGGRESSIVE SHAVER BLADE 4.2 MM BROKE DURING A PROCEDURE ON (B)(6) 2019. NOTHING FELL INTO THE PATIENT. THE SURGEON USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR SURGICAL DELAY TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE COMPLAINT DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8966026 ↗