FMS 283419Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 10886705022021), received between Apr 26, 2018 and Sep 17, 2026 — classified as 11 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Break” (61 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 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break

  It was reported that during an unknown surgery, the FMS device released metal debris from the Shaver blade. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no adverse patient consequences reported. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802644 ↗
• MalfunctionAug 5, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50138697 ↗
• MalfunctionJan 5, 2026Material Deformation

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE AGGRESSIVE 4.0MM 5PK DEVICE, THE FIRST BLADE PRESENTED A MECHANICAL FAILURE CHARACTERIZED BY FRACTURE OF THE INTERNAL SOCKET, WHICH RESULTED IN COMPLETE LOSS OF ITS FUNCTIONALITY AND MADE IT IMPOSSIBLE TO CONTINUE USE. THE SECOND SHAVER BLADE WAS OPENED, NEAR THE END OF THE PROCEDURE, BENDING OF THE BLADE WAS OBSERVED WHICH COMPROMISED ITS STABILITY AND PERFORMANCE, ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. 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 23961477 ↗
• MalfunctionJan 5, 2026Break

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE AGGRESSIVE 4.0MM 5PK DEVICE, THE FIRST BLADE PRESENTED A MECHANICAL FAILURE CHARACTERIZED BY FRACTURE OF THE INTERNAL SOCKET, WHICH RESULTED IN COMPLETE LOSS OF ITS FUNCTIONALITY AND MADE IT IMPOSSIBLE TO CONTINUE USE. THE SECOND SHAVER BLADE WAS OPENED, NEAR THE END OF THE PROCEDURE, BENDING OF THE BLADE WAS OBSERVED WHICH COMPROMISED ITS STABILITY AND PERFORMANCE, ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. 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 23961460 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, METAL SHAVINGS WERE FOUND TO HAVE FALLEN OFF FROM THE AGGRESSIVE 4.0MM 5PK DEVICE. 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 23831452 ↗
• MalfunctionOct 29, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE AGGRESSIVE 4.0MM 5PK DEVICE HAD FOREIGN MATTER. A HAND WASHING NURSE FOUND FOREIGN OBJECTS (BLACK SPOTS) IN THE PACKAGING OF A DEVICE WHILE RETRIEVING IT FROM THE HIGH-VALUE CONSUMABLES ROOM. THE KNIFE WAS UNOPENED AND NOT GIVEN TO THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 23414539 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE AGGRESSIVE 4.0MM DEVICE HAD METAL FRAGMENTS THAT CAME OUT OF THE PRODUCT IN QUESTION WHEN IT WAS USED DURING SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377787 ↗
• MalfunctionAug 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  REPORT 9 OF 9 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY; IT WAS OBSERVED THAT THE AGGRESSIVE 4.0MM 5PK DEVICE TOUCHED WATER AND IT WAS NOTED THAT WHITE FOAM WAS BETWEEN THE INNER AND OUTER SLEEVES. IT WAS REPORTED THAT THE DEVICE WAS CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ACCORDING TO THE REPORTER, THERE WAS NINE AGGRESSIVE 4.0MM 5PK DEVICES INVOLVED IN THE EVENT. 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 22826553 ↗
• MalfunctionAug 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  REPORT 7 OF 9 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY, IT WAS OBSERVED THAT THE AGGRESSIVE 4.0MM 5PK DEVICE TOUCHED WATER AND IT WAS NOTED THAT WHITE FOAM WAS BETWEEN THE INNER AND OUTER SLEEVES. IT WAS REPORTED THAT THE DEVICE WAS CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ACCORDING TO THE REPORTER, THERE WAS NINE AGGRESSIVE 4.0MM 5PK DEVICES INVOLVED IN THE EVENT. 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 22826551 ↗
• MalfunctionAug 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  REPORT 8 OF 9 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY, IT WAS OBSERVED THAT THE AGGRESSIVE 4.0MM 5PK DEVICE TOUCHED WATER AND IT WAS NOTED THAT WHITE FOAM WAS BETWEEN THE INNER AND OUTER SLEEVES. IT WAS REPORTED THAT THE DEVICE WAS CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ACCORDING TO THE REPORTER, THERE WAS NINE AGGRESSIVE 4.0MM 5PK DEVICES INVOLVED IN THE EVENT. 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 22826549 ↗
• MalfunctionAug 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  REPORT 6 OF 9 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY; IT WAS OBSERVED THAT THE AGGRESSIVE 4.0 MM 5PK DEVICE TOUCHED WATER AND IT WAS NOTED THAT WHITE FOAM WAS BETWEEN THE INNER AND OUTER SLEEVES. IT WAS REPORTED THAT THE DEVICE WAS CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ACCORDING TO THE REPORTER, THERE WAS NINE AGGRESSIVE 4.0 MM 5PK DEVICES INVOLVED IN THE EVENT. 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 22826546 ↗
• MalfunctionAug 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  REPORT 5 OF 9 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY, IT WAS OBSERVED THAT THE AGGRESSIVE 4.0MM 5PK DEVICE TOUCHED WATER AND IT WAS NOTED THAT WHITE FOAM WAS BETWEEN THE INNER AND OUTER SLEEVES. IT WAS REPORTED THAT THE DEVICE WAS CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ACCORDING TO THE REPORTER, THERE WAS NINE AGGRESSIVE 4.0MM 5PK DEVICES INVOLVED IN THE EVENT. 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 22826534 ↗
• MalfunctionAug 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  REPORT 4 OF 9 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY; IT WAS OBSERVED THAT THE AGGRESSIVE 4.0MM 5PK DEVICE TOUCHED WATER AND IT WAS NOTED THAT WHITE FOAM WAS BETWEEN THE INNER AND OUTER SLEEVES. IT WAS REPORTED THAT THE DEVICE WAS CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ACCORDING TO THE REPORTER, THERE WAS NINE AGGRESSIVE 4.0MM 5PK DEVICES INVOLVED IN THE EVENT. 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 22826529 ↗
• MalfunctionAug 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  REPORT 3 OF 9 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY, IT WAS OBSERVED THAT THE AGGRESSIVE 4.0MM 5PK DEVICE TOUCHED WATER AND IT WAS NOTED THAT WHITE FOAM WAS BETWEEN THE INNER AND OUTER SLEEVES. IT WAS REPORTED THAT THE DEVICE WAS CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ACCORDING TO THE REPORTER, THERE WAS NINE AGGRESSIVE 4.0MM 5PK DEVICES INVOLVED IN THE EVENT. 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 22826528 ↗
• MalfunctionAug 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  REPORT 2 OF 9 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY; IT WAS OBSERVED THAT THE AGGRESSIVE 4.0MM 5PK DEVICE TOUCHED WATER AND IT WAS NOTED THAT WHITE FOAM WAS BETWEEN THE INNER AND OUTER SLEEVES. IT WAS REPORTED THAT THE DEVICE WAS CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ACCORDING TO THE REPORTER, THERE WAS NINE AGGRESSIVE 4.0MM 5PK DEVICES INVOLVED IN THE EVENT. 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 22826523 ↗
• MalfunctionAug 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  REPORT 1 OF 9 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY; IT WAS OBSERVED THAT THE AGGRESSIVE 4.0MM 5PK DEVICE TOUCHED WATER AND IT WAS NOTED THAT WHITE FOAM WAS BETWEEN THE INNER AND OUTER SLEEVES. IT WAS REPORTED THAT THE DEVICE WAS CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ACCORDING TO THE REPORTER, THERE WAS NINE AGGRESSIVE 4.0MM 5PK DEVICES INVOLVED IN THE EVENT. 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 22826517 ↗
• MalfunctionJul 25, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, THE AGGRESSIVE 4.0MM 5PK DEVICE WAS BEING USED AND WHITE FOAM WAS NOTICED BETWEEN THE INNER AND OUTER SLEEVES OF THE PRODUCT AFTER IT WAS MOISTENED. THE PRODUCT HAS A RISK OF CONTAMINATION. POST HOC WASH WITH SALINE AND SOAK WITH IODOPHOR FOR 30 MIN. NO ADDITIONAL INFORMATION CAN BE PROVIDED. 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 22608192 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, IT WAS OBSERVED THAT DEBRIS FELL OFF THE AGGRESSIVE 4.0MM 5PK DEVICE AND WAS FOUND ON THE BLADE. 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 22356619 ↗
• MalfunctionJun 18, 2025Break; Break

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, IT WAS OBSERVED THAT DEBRIS FELL OFF THE AGGRESSIVE 4.0MM 5PK DEVICE AND WAS FOUND ON THE BLADE. IT WAS REPORTED THAT THE DEVICE WAS CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY AND THE SAME PROBLEM HAPPENED AGAIN. 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 22284942 ↗
• MalfunctionJun 18, 2025Break; Break

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, IT WAS OBSERVED THAT DEBRIS FELL OFF THE AGGRESSIVE 4.0MM 5PK DEVICE AND WAS FOUND ON THE BLADE. IT WAS REPORTED THAT THE DEVICE WAS CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY AND THE SAME PROBLEM HAPPENED AGAIN. 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 22284940 ↗
• MalfunctionMay 2, 2025Break; Break

  THIS IS REPORT 1 OF 2 OF (B)(4) IT WAS REPORTED THAT AT THE START OF A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING 2X AGGRESSIVE 4.0MM 5PK DEVICES IN OSCILLATING MODE, WHEN THE DEVICE STARTED SPINNING AND SHAVING NORMAL SOFT TISSUES FOR A FEW MINUTES SMALL METAL SHAVING BITS STARTED TO SHED. THE SURGEON THEN CHANGED TO TWO DIFFERENT DEVICES AND EXPERIENCED THE SAME FAILURE. THE SURGEON WAS USING FLUID MANAGEMENT SYSTEM (FMS) SETTINGS IN DEFAULT MODE. THE SURGERY WAS DELAYED FOR A FEW MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY. ALL GENERATED FRAGMENTS WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. 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 21949659 ↗
• MalfunctionMay 2, 2025Break; Break

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT AT THE START OF A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING 2X AGGRESSIVE 4.0MM 5PK DEVICES IN OSCILLATING MODE, WHEN THE DEVICE STARTED SPINNING AND SHAVING NORMAL SOFT TISSUES FOR A FEW MINUTES SMALL METAL SHAVING BITS STARTED TO SHED. THE SURGEON THEN CHANGED TO TWO DIFFERENT DEVICES AND EXPERIENCED THE SAME FAILURE. THE SURGEON WAS USING FLUID MANAGEMENT SYSTEM (FMS) SETTINGS IN DEFAULT MODE. THE SURGERY WAS DELAYED FOR A FEW MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY. ALL GENERATED FRAGMENTS WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. 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 21949647 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY IT WAS OBSERVED THAT THE AGGRESSIVE 4.0MM DEVICE HAD METAL SHEDDING. IT WAS REPORTED THAT SHAVINGS FELL INSIDE THE PATIENT AND THE SURGEON USED SUCTION TO CLEAN UP AND MOST SHAVINGS WERE REMOVED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21932948 ↗
• MalfunctionApr 1, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER JOINT SURGICAL PROCEDURE THE AGGRESSIVE 4.0 MM 5PK DEVICE METAL SHAVINGS FELL OFF. THE DEVICE WAS NOTED TO HAVE METAL DEBRIS FALLING OFF. 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 21742450 ↗
• MalfunctionApr 1, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER JOINT PROCEDURE, IT WAS DISCOVERED THAT A METAL PIECE ON THE AGGRESSIVE 4.0MM 5PK DEVICE FELL OFF. 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 21739864 ↗