FMS 283469Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10886705022045), received between Aug 6, 2018 and Jan 21, 2026 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (15 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Mechanical Jam; Noise, Audible

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE BARREL BURR 4.0MM DEVICE WAS JAMMED/SEIZED. IT WAS INITIALLY REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR ON THE SHOULDER FOR A ROTATOR CUFF TEAR, THE DEVICE ATTACHED TO A HANDPIECE PRODUCED A STRANGE NOISE DURING USE AND BECAME UNUSABLE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED 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 24133541 ↗
• MalfunctionJun 13, 2025Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS FOUND THAT THE BARREL BURR 4.0MM 5PK DEVICE BECAME STUCK DURING USE AND COULD NOT BE UNLOCKED. 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 22202379 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS FOUND THAT THE BARREL BURR 4.0MM DEVICE HAD METAL ABRASION THAT WAS PRESENT RIGHT OUT OF THE BOX. 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 21873587 ↗
• MalfunctionJun 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 WHILE USING THE BARREL BURR 4.0MM 5PK DEVICE, AFTER BEING INSERTED UNDER THE ACROMION FOR SUBACROMIAL DECOMPRESSION TO PERFORM DRILLING, AN ALARM SOUNDED FROM THE FMS MAIN UNIT WITHIN A FEW SECONDS. THEN, IT COULD NO LONGER BE USED FOR SURGERY. WHEN THE BARREL BURR WAS REMOVED FROM THE HAND PIECE FROM, THE INNER TUBE WAS DEFORMED AND COULD NOT BE PULLED OUT. THE SURGEON HAS BEEN THINKING THAT BARREL BURR WAS EASILY BENT FOR SOME TIME, AND IT BECAME UNUSABLE WITHIN FEW SECONDS DESPITE CAREFUL OPERATION. AN OMNICUT WAS USED FOR SURGERY INSTEAD OF THE BARREL BURR. IN ADDITION, THE ANCHOR IN QUESTION BROKE OFF WHEN TRYING TO THREAD ONE SET OF TAPE AND ONE SET OF SUTURE THROUGH THE ANCHOR FOR BRIDGING. 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. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605382 ↗
• MalfunctionNov 2, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN LUXEMBOURG THAT BEFORE AN UNKNOWN ARTHROSCOPIC PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4 MM BARREL BUR PLUS DEVICE WAS BLOCKED AND DID NOT TURN ANYMORE. THERE WAS NO PATIENT INVOLVEMENT. 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 18055903 ↗
• MalfunctionOct 2, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN LUXEMBOURG THAT DURING AN SHOULDER SCOPE PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE BLADE ON THE 4 MM BARREL BUR PLUS DEVICE WAS STUCK AND DID NOT REACT ANYMORE; AND THAT IT WAS IMPOSSIBLE TO DISLOCATE THE TWO PARTS ON THE DEVICE AFTER THAT. 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 17856433 ↗
• MalfunctionApr 18, 2023Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  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 BARREL BUR PLUS DEVICE STOPPED WORKING AND ROTATING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE INNER SHAFT ON THE DEVICE WAS SEIZED; AND THAT IT WAS NOT POSSIBLE TO SPIN TO ANY DIRECTION OR SEPARATE. 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 16764382 ↗
• MalfunctionAug 11, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN BRAZIL THROUGH HEALTH AUTHORITY THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4 MM BARREL BUR PLUS DEVICE LOCKED 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 15212036 ↗
• MalfunctionAug 8, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN GERMANY THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4 MM BARREL BUR PLUS DEVICE WAS BROKEN. 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 15188434 ↗
• MalfunctionAug 1, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE CUSTOMER IN CHINA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4 MM BARREL BUR PLUS DEVICE WAS STUCK UPON OPENING ITS PACKAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15140362 ↗
• MalfunctionJun 16, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN BRAZIL THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE BLADE DEVICE WAS STUCK AND BROKE DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14715937 ↗
• MalfunctionJun 16, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN BRAZIL THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE BLADE DEVICE WAS STUCK, MAKING IT IMPOSSIBLE TO USE. 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 14715834 ↗
• MalfunctionMar 25, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SUBACROMIAL DECOMPRESSION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THERE WERE NO BUBBLES BEING GENERATED DURING SUCTION ON THE BARREL BURR 4.0MM DEVICE. ACCORDING TO THE REPORT, BUBBLES WERE GENERATED WHEN THE SUCTION WAS APPLIED WITH THE DEVICE IN THE LESION BUT DISAPPEARED AFTER TWO MINUTES. THE PROCEDURE WAS DELAYED LESS THAN 30 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13903229 ↗
• MalfunctionFeb 7, 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 FEW METAL PARTS IN THE SHOULDER JOINT WHILE USING THE BARREL BURR 4.0MM BLADE DEVICE. ACCORDING TO THE REPORTER, IT WAS UNKNOWN IF ALL FRAGMENTS WERE REMOVED FROM THE PATIENT'S BODY. THERE WAS NO PROCEDURE SCHEDULED TO REMOVE FRAGMENTS. 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 13472782 ↗
• MalfunctionNov 9, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE OUTER SHEATH THAT COVERED THE TIP OF THE BARREL BURR 4.0MM DEVICE COMPLETELY FRAGMENTED WHEN IT WAS IN CONTACT WITH BONE. AS THE SHEATH SHREDDED INTO LONG PIECES, IT DISPERSED INTO PATIENTS ANKLE JOINT. METAL FRAGMENTS THAT WERE VISIBLE AND REMOVEABLE WERE TAKEN OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. WITH A DELAY OF FIVE TO TEN MINUTES TO CLEAR METAL DEBRIS FROM THE PATIENT. 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 12781127 ↗
• MalfunctionNov 9, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE OUTER SHEATH THAT COVERED THE TIP OF THE BARREL BURR 4.0MM DEVICE COMPLETELY FRAGMENTED WHEN IT WAS IN CONTACT WITH BONE. AS THE SHEATH SHREDDED INTO LONG PIECES, IT DISPERSED INTO PATIENTS ANKLE JOINT. METAL FRAGMENTS THAT WERE VISIBLE AND REMOVEABLE WERE TAKEN OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. WITH A DELAY OF FIVE TO TEN MINUTES TO CLEAR METAL DEBRIS FROM THE PATIENT. 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 12781126 ↗
• MalfunctionDec 22, 2020Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE BARREL BURR 4.0MM 5PK DEVICE ROTATED ECCENTRICALLY AND RE-ATTACHMENT DID NOT CORRECT THE ISSUE. WHEN A REPLACEMENT WAS ATTACHED, THE ISSUE WAS CORRECTED. THERE WERE NO DELAYS IN THE PROCEDURE AND 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 11056037 ↗
• MalfunctionDec 10, 2019Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED BY THE AFFILIATE, VIA COMPLAINT SUBMISSION TOOL, DURING AN SAS RC REPAIR PROCEDURE METAL ABRASIONS RELEASED FROM THE BARREL BURR 4.0MM. THE AFFILIATE REPORTED SURGICAL DELAY AND SURGICAL INTERVENTION DID NOT OCCUR. IT WAS REPORTED AN ALTERNATIVE DEVICE WAS READILY AVAILABLE BUT NOT USED BECAUSE THE SAME BURR WAS USED TO COMPETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9447882 ↗
• MalfunctionOct 8, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING A SUBACROMIAL DECOMPRESSION PROCEDURE THE 4MM BARREL BURR PLUS SEIZED UP. AFTER REMOVED FROM THE SHOULDER THE INNER BLADE WAS STUCK IN THE OUTER BLADE. THE DEVICE WAS ONLY IN USE FOR APPROXIMATELY 15 SECONDS BEFORE THE ISSUE OCCURRED. SWAPPED BURR TO RESOLVE ISSUE. THERE WAS NO PATIENT HARM BUT THERE WAS ONLY 30 SECONDS SURGICAL DELAY TO REPLACE THE BURR WITH A NEW ONE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9168807 ↗
• MalfunctionOct 4, 2019Mechanical Jam; Mechanical Jam

  AS PER THE SALES REP VIA EMAIL, FMS PUMP BEGAN BEEPING DURING A SUBACROMIAL DECOMPRESSION PROCEDURE AND THE MICRO TORNADO HANDPIECE WITH HAND CONTROLS WOULD NOT ACTIVATE. A NEW HANDPIECE WAS OPENED, AND ISSUE WAS RESOLVED. SINCE BOTH HANDPIECES WERE OPENED ON THE STERILE FIELD, AFTER THE CASE THE SALES REP WAS UNABLE TO DETERMINE WHICH HANDPIECE WAS THE DEFECTIVE ONE. SALES REP IS RETURNING BOTH HANDPIECES AND NEEDS TWO REPLACEMENTS. ALSO, DURING THE SAME PROCEDURE THE 4 MM BARREL BUR PLUS SEIZED UP. AFTER REMOVED FROM THE SHOULDER THE INNER BLADE WAS STUCK IN THE OUTER BLADE. SWAPPED BURR TO RESOLVE ISSUE. THE DEVICE HAD ONLY BEEN IN USE FOR APPROXIMATELY TWO MINUTES WHEN THE ISSUE OCCURRED. THERE WAS NO PATIENT HARM BUT THERE WAS ONLY 30 SECONDS SURGICAL DELAY TO THE CASE TO REPLACE THE BURR WITH A NEW ONE. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9158310 ↗
• MalfunctionJun 3, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THE 4 MM BARREL BURR WAS WORKING, BUT THEN THERE WAS A BEEP AND THE BURR DID NOT ROTATE. THE SURGEON DETACHED THE BURR FROM THE HANDPIECE AND RECOGNIZED THAT THE INNER AND OUTER BURR WAS STUCK. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS LESS THAN A THIRTY MINUTE SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WAS PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 8663687 ↗
• MalfunctionFeb 20, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE VIA CST TOOL THAT DURING AN UNKNOWN PROCEDURE THE BURR STOPPED ROTATING. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM OR TIME DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8356221 ↗
• MalfunctionNov 14, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE SURGEON RECOGNIZED THAT THERE WAS AN ABNORMAL METAL NOISE WHEN DRILLING THE PATIENT¿S BONE DURING ARCR SURGERY. THEN, THE ERROR MESSAGE WAS DISPLAYED AND STOPPED WORKING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THERE WAS A WHITE SUBSTANCE WHEN INSPECTING THE OUTER HUB ON THE INSIDE OF THE BLADE ON THE DEVICE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED BY USING ALTERNATIVE DEVICE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS BRAND NEW AND ON ITS FIRST USE WHEN THE ISSUE OCCURRED. 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 8070968 ↗
• MalfunctionOct 2, 2018Component Incompatible; Mechanical Jam; Component Incompatible; Mechanical Jam

  IT WAS REPORTED BY AN AFFILIATE THAT DURING A SHOULDER ARTHROSCOPY, THE BLADE (PRODUCT: 283469 - LOT: M1701009) OF SHAVER BONE PARTS PRESENTED LOCKING. AFTER SEVERAL ATTEMPTS TO REPAIR THE BLADE IT WORKED, BUT PRESENTED NOISES DIFFERENT THAN NORMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926876 ↗
• InjuryAug 30, 2018Break; Break

  IT WAS REPORTED THAT DURING ANKLE SURGERY (ARTHROSCOPY), METAL ABRASION WAS DETECTED. THE PATIENT CONSEQUENCE IS THAT THERE'S STILL SOME BURR IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7834873 ↗