FMS 283459Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886705025428), received between Apr 3, 2018 and Mar 26, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Mechanical Jam; Output Problem; Noise, Audible

  IT WAS REPORTED THAT DURING DEVICE EVALUATION, IT WAS DETERMINED THAT THE INNER SHAFT OF THE 4.0MM ROUND BURR DEVICE WAS SEIZED, IT WAS NOT POSSIBLE TO SPIN TO ANY DIRECTION. IT WAS NOTED IN THE SERVICE ORDER THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) FOR ROTATOR CUFF TEARS (RCT) OF THE SHOULDER, THE SHAVER HAD MADE A STRANGE NOISE WHILE IN USE, HAD STOPPED WORKING, AND WAS NO LONGER USABLE. EVEN AFTER CHANGING THE HANDPIECE, IT STILL WOULDN'T WORK, AND EVEN AFTER CHANGING THE SHAVER TIP, IT STOPPED WORKING AGAIN. THE THIRD SHAVER WAS STILL USABLE UNTIL THE LATTER HALF OF THE OPERATION. THERE WERE NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699165 ↗
• MalfunctionMar 26, 2026Mechanical Jam; Output Problem; Noise, Audible

  IT WAS REPORTED THAT DURING DEVICE EVALUATION, IT WAS DETERMINED THAT THE INNER SHAFT OF THE 4.0MM ROUND BURR DEVICE WAS SEIZED, IT WAS NOT POSSIBLE TO SPIN TO ANY DIRECTION. IT WAS NOTED IN THE SERVICE ORDER THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) FOR ROTATOR CUFF TEARS (RCT) OF THE SHOULDER, THE SHAVER HAD MADE A STRANGE NOISE WHILE IN USE, HAD STOPPED WORKING, AND WAS NO LONGER USABLE. EVEN AFTER CHANGING THE HANDPIECE, IT STILL WOULDN'T WORK, AND EVEN AFTER CHANGING THE SHAVER TIP, IT STOPPED WORKING AGAIN. THE THIRD SHAVER WAS STILL USABLE UNTIL THE LATTER HALF OF THE OPERATION. THERE WERE NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699154 ↗
• MalfunctionMar 26, 2026Mechanical Jam; Output Problem; Noise, Audible

  IT WAS REPORTED THAT DURING DEVICE EVALUATION, IT WAS DETERMINED THAT THE INNER SHAFT OF THE 4.0MM ROUND BURR DEVICE WAS SEIZED, IT WAS NOT POSSIBLE TO SPIN TO ANY DIRECTION. IT WAS NOTED IN THE SERVICE ORDER THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) FOR ROTATOR CUFF TEARS (RCT) OF THE SHOULDER, THE SHAVER HAD MADE A STRANGE NOISE WHILE IN USE, HAD STOPPED WORKING, AND WAS NO LONGER USABLE. EVEN AFTER CHANGING THE HANDPIECE, IT STILL WOULDN'T WORK, AND EVEN AFTER CHANGING THE SHAVER TIP, IT STOPPED WORKING AGAIN. THE THIRD SHAVER WAS STILL USABLE UNTIL THE LATTER HALF OF THE OPERATION. THERE WERE NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699152 ↗
• MalfunctionJan 28, 2026Mechanical Jam; Output Problem; Noise, Audible

  IT WAS REPORTED THAT THIS WAS AN ARTHROSCOPIC ROTATOR CUFF REPAIR ON SHOULDER FOR ROTATOR CUFF TEAR PERFORMED. DURING SURGERY, WHILE THE SURGEON WAS PERFORMING ARTHROSCOPIC SUBACROMIAL DECOMPRESSION, THE 4.0MM ROUND BURR PLUS 5PK MADE A STRANGE NOISE AND STOPPED WORKING. WHEN THE PRODUCT IN QUESTION WAS REMOVED FROM THE HANDPIECE, THE INNER TUBE COULD NOT BE REMOVED. THE SURGEON USED IT APPROPRIATELY AND THERE WERE NO PROBLEMS. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199862 ↗
• MalfunctionJan 12, 2026Mechanical Jam; Noise, Audible

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, WHILE USING THE 4.0MM ROUND BURR PLUS DEVICE THERE WAS A STRANGE NOISE COMING FROM THE ROUND BURR, AND THE INNER AND OUTER TUBES LOCKED AND COULD NO LONGER MOVE. IT WAS REPORTED THAT AFTER THE PROCEDURE, AN ATTEMPT WAS MADE TO REMOVE THE INNER TUBE, BUT THE TUBE WAS COMPLETELY STUCK AND COULD NOT BE REMOVED. THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032158 ↗
• MalfunctionJan 7, 2026Infusion or Flow Problem; Output Problem; Unintended Movement

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) ON THE SHOULDER FOR ROTATOR CUFF TEAR, IT WAS OBSERVED THAT THE SUCTION OF THE 4.0MM ROUND BURR PLUS SYSTEM SUDDENLY STOPPED WORKING. IT WAS REPORTED THAT THE SURGEON STOPPED USING THE DEVICE AND SEPARATED THE INNER AND OUTER TUBES. IT WAS OBSERVED THAT A THIN, TRANSPARENT, RUBBER-LIKE MEMBRANE ATTACHED TO THE OUTER SURFACE OF THE INNER TUBE HAD GATHERED AT THE DISTAL END, AND IT APPEARED THAT THIS BLOCKAGE BETWEEN THE INNER AND OUTER TUBES WAS THE REASON THE SUCTION STOPPED WORKING. FURTHERMORE, WHEN ATTEMPTING TO REINSERT THE INNER CYLINDER INTO THE OUTER CYLINDER, THE GATHERED PORTION OBSTRUCTS THE PROCESS, MAKING IT IMPOSSIBLE TO RETURN IT TO ITS ORIGINAL POSITION. A REPLACEMENT UNIT FOR THE SAME PRODUCT WAS OPENED AND USED. THE SURGEON NOTED THAT WHEN USING THE PRODUCT, CENTRIFUGAL FORCE CAUSES THE THIN TRANSPARENT RUBBER MEMBRANE ATTACHED TO THE MIDDLE TUBE TO BE PUSHED DISTALLY AND GATHERED, WHICH MAY RESULT IN THE SHAVER MAKING A STRANGE NOISE AND STOPPING OR BECOMING UNABLE TO PRODUCE SUCTION. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990948 ↗
• MalfunctionDec 31, 2025Degraded; Mechanical Jam; Degraded; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) ON SHOULDER FOR ROTATOR CUFF TEAR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.0MM ROUND BURR PLUS 5PK DEVICE SUDDENLY LOCKED AND COULD NO LONGER BE USED. IN ORDER TO GRIND THE BONE, THE ROUND BURR DEVICE WAS PRESSED AGAINST THE BONE, AND IT WAS ASSUMED THAT THIS PUT STRESS ON THE BASE OF THE BUR. HOWEVER, THE CAUSE WAS UNKNOWN. 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 23936966 ↗
• MalfunctionAug 27, 2025Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ELBOW SURGERY, IT WAS OBSERVED THAT THE 4.0MM ROUND BURR PLUS 5PK DEVICE DID NOT WORK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE INNER SHAFT WAS JAMMED AND WAS UNABLE TO BE DISASSEMBLED. 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 22901946 ↗
• MalfunctionDec 27, 2024Break; Output Problem; Break; Output Problem

  IT WAS REPORTED FROM SWITZERLAND THAT DURING AN ARTHROSCOPIC SURGICAL PROCEDURE IT WAS OBSERVED THAT AFTER A SHORT PERIOD OF USE, THE 4.0MM ROUND BURR PLUS SHAVER WITH THE BURR STOPPED WORKING. IT WAS REPORTED THAT THE BURR ATTACHMENT WAS DISCONNECTED FROM THE SHAVER HANDPIECE, AND FINE BROKEN PLASTIC PARTICLES COULD BE SEEN ON THE CONNECTING PIECE BETWEEN THE SHAVER HANDPIECE AND THE BURR. IT WAS REPORTED THAT THE GENERATED FRAGMENTS DID NOT COME INTO CONTACT WITH THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW BURR. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028450 ↗
• MalfunctionAug 7, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE, IT WAS OBSERVED THAT THE 4.0MM ROUND BURR PLUS DEVICE WAS BLOCKED THAT IT WAS NOT POSSIBLE TO SLIDE OUT THE INNER PART OF THE SHAVER TO CLEAN IT AS IT WAS BLOCKED COMPLETELY. 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 19932033 ↗
• MalfunctionDec 7, 2023Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE ON (B)(3) 2023 SCRAPED BONE WAS STUCK BETWEEN THE INNER AND THE OUTER OF THE 4.0MM ROUND BURR DEVICE AND IT STOPPED ROTATING. AN ERROR SOUND BEEPED FROM THE MAIN UNIT. A SPARE ROUND BURR WAS OPENED AND USED WITH NO PROBLEM. THERE WAS NO HARM TO THE PATIENT. THE EXTENDED SURGERY TIME WAS LESS THAN THIRTY MINUTES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282921 ↗
• MalfunctionJun 29, 2022Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4 MM ROUND BURR PLUS DEVICE GOT STUCK AND STOPPED WORKING WHILE CARRYING OUT THE REMODELING OF THE CLAVICLE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS JAMMED/SEIZED AND WOULD NOT ROTATE. 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 14853637 ↗
• MalfunctionMay 3, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED ARTHROCOPIC SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE REPORTED DEVICE SUDDENLY STOPPED WITH BEEP. ACCORDING TO THE REPORTER, AT THE BEGINNING OF THE SURGERY, THE DEVICE WAS NORMALLY OPERATED WITH THE HANDPIECE (P/N: 283512, LOT NUMBER WAS UNKNOWN). THERE WAS NO ERROR MESSAGE ON THE DISPLAY WHEN THE ERROR OCCURRED. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE DEVICE (SAME P/N, LOT NUMBER WAS UNKNOWN). IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO INFORMATION FOR THE SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE BLADES WERE JAMMED. 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 8579218 ↗
• MalfunctionApr 3, 2018Metal Shedding Debris; Metal Shedding Debris

  DURING THE SURGERY THE COATING OF THE BURR WAS GETTING LOOSE IN THE ANKLE JOINT. THEY HAD TO REMOVE ALL THE PARTS OF THE COATING OUT OF THE JOINT. THE PATIENT WAS AWAKE DURING THE SURGERY AND SAW WHAT WAS HAPPENING AND ASKED THE SURGEON WHY ALL THE COATING PARTS WERE LOOSE IN HIS ANKLE JOINT. THE SURGEON HAD TO EXPLAIN WHAT WAS HAPPENING WITH THE BURR DURING THE SURGERY WHAT MAKES IT A VERY UNCOMFORTABLE AND UNPROFESSIONAL SITUATION. AFTER ALL THE COATING PARTS WERE REMOVED THE SURGERY FINISHED WELL. PROCEDURE WAS ANKLE ARTHROSCOPY AND THERE WAS A 10 MINUTES DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7392727 ↗