FMS 283409Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10886705022014), received between Apr 24, 2018 and Apr 16, 2026 — classified as 9 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (36 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGERY, WHILE USING THE FULL RADIUS 4.0MM 5PK DEVICE, METAL PARTICLES WERE SEEN IN THE JOINT SPACE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 24896106 ↗
• MalfunctionJan 9, 2026Use of Device Problem; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020698 ↗
• MalfunctionJan 9, 2026Use of Device Problem; Mechanical Jam

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, AFTER CONNECTING THE FULL RADIUS 4.0MM 5PK DEVICE, IT BECAME STUCK AND WAS NONFUNCTIONAL, AND THE SCREEN SHOWED NO ALERT CODE. TWO REPLACEMENT DEVICES WERE USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. 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 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 24020697 ↗
• MalfunctionJan 9, 2026Use of Device Problem; Mechanical Jam

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, AFTER CONNECTING THE FULL RADIUS 4.0MM 5PK DEVICE, IT BECAME STUCK AND WAS NONFUNCTIONAL, AND THE SCREEN SHOWED NO ALERT CODE. TWO REPLACEMENT DEVICES WERE USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. 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 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 24020695 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS METAL ABRASION WHILE USING THE FULL RADIUS 4.0MM DEVICE WITH THE SHAVER ATTACHMENT. IT WAS FURTHER REPORTED THAT IT WAS A POWDER-LIKE DUSTING, NOT METAL SHAVINGS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888170 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS METAL ABRASION WHILE USING THE FULL RADIUS 4.0MM DEVICE WITH THE SHAVER ATTACHMENT. IT WAS FURTHER REPORTED THAT IT WAS A POWDER-LIKE DUSTING, NOT METAL SHAVINGS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888166 ↗
• MalfunctionDec 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE FULL RADIUS 4.0MM 5PK DEVICE, THE SHAVER BLADE COULD NOT BE CONNECTED TO THE HANDPIECE. IT JUST DID NOT FIT IN. THE USER ATTEMPTED TO USE ANOTHER BLADE DEVICE BUT THE SAME ERROR OCCURRED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A FIVE-MINUTE DELAY IN THE PROCEDURE REPORTED. NO FRAGMENTS WERE GENERATED. 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 23838688 ↗
• MalfunctionDec 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE FULL RADIUS 4.0MM 5PK DEVICE, THE SHAVER BLADE COULD NOT BE CONNECTED TO THE HANDPIECE. IT JUST DID NOT FIT IN. THE USER ATTEMPTED TO USE ANOTHER BLADE DEVICE BUT THE SAME ERROR OCCURRED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A FIVE-MINUTE DELAY IN THE PROCEDURE REPORTED. NO FRAGMENTS WERE GENERATED. 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 23838683 ↗
• MalfunctionDec 16, 2025Break; Break

  REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGICAL PROCEDURE, WHILE USING 3X FULL RADIUS 4.0MM 5PK DEVICES, IT WAS OBSERVED THAT METAL ABRASION OCCURRED. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23814351 ↗
• MalfunctionDec 16, 2025Break; Break

  REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGICAL PROCEDURE, WHILE USING 3X FULL RADIUS 4.0MM 5PK DEVICES, IT WAS OBSERVED THAT METAL ABRASION OCCURRED. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23814337 ↗
• MalfunctionDec 16, 2025Break; Break

  REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGICAL PROCEDURE, WHILE USING 3X FULL RADIUS 4.0MM 5PK DEVICES, IT WAS OBSERVED THAT METAL ABRASION OCCURRED. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23814297 ↗
• MalfunctionJun 9, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE FULL RADIUS 4.0MM 5PK DEVICE WAS CHARACTERIZED AS ¿INORGANIC.¿ 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. 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 22166769 ↗
• MalfunctionDec 20, 2024Break; Break

  IT WAS REPORTED FROM SWITZERLAND THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE METAL DEBRIS OCCURRED WHEN USING THE FULL RADIUS 4.0MM SHAVER BLADE. ALL DEBRIS WAS REMOVED FROM THE PATIENT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 3-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20988113 ↗
• MalfunctionAug 27, 2024Break; Noise, Audible; Break; Noise, Audible

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AN FMS FULL RADIUS BLADE PLUS 4.0MM DEVICE AND A SHAVER HANDPIECE 2.0 WITHOUT BUTTONS DEVICE WERE USED TOGETHER. ACCORDING TO THE REPORT, THE SHAVER MADE A RANDOM LOUD AND SCRATCHY SOUND LIKE "NAILS ON CHALKBOARD" THEN SHOT OUT METAL SHAVINGS EVERYWHERE IN THE JOINT. IT WAS FURTHER REPORTED THAT THE SHAVER HAD AN ERROR CODE FC014. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE. 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 20076444 ↗
• MalfunctionMay 14, 2024Break; Break

  IT WAS REPORTED FROM SWITZERLAND THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE FULL RADIUS 4.0MM SHAVER DEVICE IT WAS OBSERVED THAT THERE WERE BITS OF THE METAL IN THE KNEE. IT IS UNKNOWN IF THE FRAGMENTS WERE REMOVED. 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 19311174 ↗
• MalfunctionMay 1, 2024Break; Break

  IT WAS REPORTED FROM SWITZERLAND THAT DURING A KNEE ARTHROSCOPY SURGICAL PROCEDURE IT WAS OBSERVED THAT THERE WERE LITTLE METAL BITS IN THE KNEE JOINS THAT CAME FROM THE FULL RADIUS 4.0MM 5PK SHAVER 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 19221282 ↗
• MalfunctionFeb 6, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4 MM FULL RADIUS BLADE PLUS DEVICE SHOWED SOME METAL ABRASIONS. 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 16306822 ↗
• MalfunctionNov 4, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND IN THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THERE INTERARTICULAR METALLOSIS DURING SHAVER OPERATION WHILE USING THE 4 MM FULL RADIUS BLADE PLUS DEVICE. ACCORDING TO THE REPORT, THE METAL ABRASION HAD HAPPENED WHEN TURNING IN REVERSE. THERE WAS UNSPECIFIED DELAY IN THE SURGERY. THERE WAS NO ADDITIONAL MEDICAL OF SURGICAL TREATMENT REQUIRED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15731574 ↗
• MalfunctionDec 8, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN DURING KNEE ARTHROSCOPY SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THERE METAL SPREADS IN THE KNEE JOINT WHILE USING THE FULL RADIUS 4.0MM BLADE DEVICE. ALL THE FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. 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 12963668 ↗
• MalfunctionDec 1, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(4) THAT DURING A KNEE ARTHROSCOPY SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE FULL RADIUS 4.0MM BLADE DEVICE HAD METAL ABRASION. THERE WERE NO FRAGMENTS GENERATED. 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 12912958 ↗
• MalfunctionDec 1, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A KNEE ARTHROSCOPY SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE FULL RADIUS 4.0MM BLADE DEVICE HAD METAL ABRASION. THERE WERE NO FRAGMENTS GENERATED. 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 12912914 ↗
• InjuryJun 17, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THERE WERE METAL DEBRIS WHEN USING THE 4 MM FULL RADIUS BLADE PLUS DEVICE. THERE WERE FRAGMENTS GENERATED BUT WERE NOT ALL REMOVED BY SUCTION. IT WAS REPORTED THAT THERE WILL NOT BE A PROCEDURE TO REMOVE THE REST OF THE FRAGMENTS. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12016312 ↗
• MalfunctionApr 1, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT METAL SHAVING CAME OFF THE BLADE DEVICE. ACCORDING TO THE REPORT, THE EVENT OCCURRED WHEN THE DOCTOR PRESSED THE OSCILLATE BUTTON UPON INSERTING THE BLADE INTO THE SHOULDER NEXT TO THE GLENOID. THE SURGEON SPENT SIX TO EIGHT MINUTES USING ANOTHER LIKE DEVICE WITH SUCTION TO REMOVE THE METAL SHAVINGS FROM THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11604032 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 4 MM FULL RADIUS BLADE PLUS DEVICE HAD SMALL METAL SHARDS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590813 ↗
• InjuryDec 21, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANKLE ARTHROSCOPY RECONSTRUCTION PROCEDURE FOR CARTILAGE REPAIR ON (B)(6) 2020, IT WAS OBSERVED THAT THE FULL RADIUS 4.0MM 5PK SHAVER BLADE DEVICE SPREAD METAL ON THE ANKLE JOINT. THERE WAS A DELAY OF TEN MINUTES TO FINISH THE CARTILAGE REPAIR BUT THERE WERE SOME METAL PARTS REMAINED INSIDE THE PATIENT. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11045948 ↗