Arthrex® AR-7300DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00888867041943), received between Mar 16, 2017 and Nov 25, 2025 — classified as 15 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (26 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 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY WHEN USING THE SHAVER THE TIP OF THE DISSECTOR AR-7300DS BROKE OFF. NOTHING REMAINED IN THE PATIENT, EVERYTHING HAS BEEN REMOVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643244 ↗
• MalfunctionNov 13, 2025Material Fragmentation; Material Fragmentation

  ON 10/29/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-7300DS 3MM X 7CM DISSECTOR HAD METAL SHAVINGS/SPECS OF METAL THAT CAME OFF AS IT SHAVED THE BONE DURING AN ANKLE ARTHROSCOPY PROCEDURE. THEY WERE ABLE TO USE A SUCTION TO GET THE METAL SHAVERS OUT OF THE PATIENT, WHO WAS UNAFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541917 ↗
• MalfunctionOct 30, 2025Material Discolored; Material Discolored

  ON 09/30/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7300DS DISSECTOR HAS WEAR MARKS AT THE SHP CONNECTION. THE PHOTO PROVIDED BY THE SALES REP SHOWED DISCOLORATION ALONG THE SHAFT OF THE DISSECTOR. PER THE SALES REP, THE OTHER DEVICES BEING USED WITH THE DISSECTOR WERE AR-8330H SHAVER HANDPIECE, AN AR-8305 SYNERGY SHAVER CONSOLE, AND AN AR-8310 SHAVER FOOTSWITCH. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MEDWATCH ON 10/10/2025: A FACILITY REPRESENTATIVE REPORTED THAT AN AR-8305 SYNERGY RESECTION SHAVER CONSOLE WAS USED DURING A PROCEDURE ON (B)(6) 2025. AFTER THE SURGEON REMOVED THE ARTHROSCOPIC SHAVER FROM THE PATIENT AND WAS ABOUT TO PLACE IT ON THE MAYO STAND, THE SURGICAL TEAM OBSERVED THAT THE DEVICE REMAINED ACTIVE DESPITE THE SWITCH BEING TURNED OFF. ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE ON 10/15/2025: PER THE REP, THE EVENT OCCURRED OUTSIDE THE PATIENT, ON THE MAYO STAND, AFTER THE AR-7300DS HAD BEEN USED AND WAS NO LONGER REQUIRED FOR THE PROCEDURE. IT IS UNKNOWN HOW LONG THE AR-7300DS WAS USED CONTINUOUSLY, AND WHETHER ANY WEAR MARKS WERE PRESENT AT THE PROXIMAL END WHERE IT CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429804 ↗
• MalfunctionMay 27, 2025Overheating of Device; Overheating of Device

  ON 05/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7300DS DISSECTOR TIP OVERHEATED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT REPORTED. THERE WAS NO BURNS TO THE PATIENT. NO DELAY TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087616 ↗
• MalfunctionMay 27, 2025Overheating of Device; Overheating of Device

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06877418 THAT AN AR-7300DS DISSECTOR TIP OVERHEATED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT REPORTED. THERE WAS NO BURNS TO THE PATIENT. NO DELAY TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087432 ↗
• MalfunctionMay 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE SHAVER CABLE PRODUCED METAL DEBRIS. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE CMACKENBACH 08-MAY-2025: FURTHER INFORMATION WAS RECEIVED THAT THE INITIAL PROVIDED INFORMATION WAS PARTLY INCORRECT. IT WAS REPORTED THAT THE SHAVER BLADE PRODUCED METAL DEBRIS (NOT THE CABLE). ALL METAL FRAGMENTS COULD BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039274 ↗
• MalfunctionMay 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE SHAVER CABLE PRODUCED METAL DEBRIS. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE CMACKENBACH (B)(6) 2025 FURHTER INFORMATION WAS RECEIVED THAT THE INITIAL PROVIDED INFORMATION WAS PARTLY INCORRECT. IT WAS REPORTED THAT THE SHAVER BLADE PRODUCED METAL DEBRIS (NOT THE CABLE). ALL METAL FRAGMENTS COULD BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038996 ↗
• MalfunctionFeb 25, 2025Break; Break

  ON 02/13/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-7300DS 3MM X 7CM DISSECTOR TIP OF THE INSIDE PORTION OF THE SHAVER BROKE OFF INSIDE THE PATIENT DURING AN ANKLE SCOPE. THANKFULLY, SHE TOOK AN X-RAY AT THE END OF THE CASE AND NOTICED THE BROKEN PIECE AND WAS ABLE TO LOCATE AND REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460330 ↗
• MalfunctionNov 26, 2024Overheating of Device; Overheating of Device

  ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06697273 THAT AN AR-7300DS DISSECTOR SHAVER BLADE HEATED UP WHICH CAUSED DISCOLORATION TO THE SHAVER. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789923 ↗
• MalfunctionOct 17, 2024Overheating of Device; Overheating of Device

  ON 9/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-7300DS DISSECTOR BECAME VERY HOT AND FUSED TOGETHER AND IT COULD NOT BE REMOVED PROPERLY FROM THE HANDPIECE. THE DISSECTOR WAS CHANGED TO ANOTHER FROM THE SAME LOT NUMBER, AND THE SAME THING HAPPENED. THIS WAS DISCOVERED DURING A WRIST SCOPE PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 10/3/2024: THE DISSECTOR DID NOT PRODUCE SMOKE. THE DISSECTOR SLIGHTLY BURNED THE PATIENT'S TISSUE. NO OPERATING ROOM STAFF WAS HARMED BY THE OVERHEATED DISSECTOR. THE DISSECTOR PRODUCED METAL SHAVINGS, AND THEY WERE CLEANED OUT WITH THE AR-7300RBE BURR USED TO COMPLETE THE CASE. A DUALWAVE OUTFLOW TUBING, A PUMP, AND VACUUM/WALL SUCTION WERE NOT USED DURING THE CASE. THERE WAS NO UNINTERRUPTED FLOW OF IRRIGATION THROUGH THE DEVICE WHILE IN USE. THE AR-7300DS DISSECTOR WAS USED IN OSCILLATION AND FORWARD DIRECTION. THE CASE WAS DELAYED TEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Burn(s)

  MAUDE report 20472929 ↗
• InjuryOct 17, 2024Overheating of Device; Overheating of Device

  ON 9/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-7300DS DISSECTOR BECAME VERY HOT AND FUSED TOGETHER AND IT COULD NOT BE REMOVED PROPERLY FROM THE HANDPIECE. THE DISSECTOR WAS CHANGED TO ANOTHER FROM THE SAME LOT NUMBER, AND THE SAME THING HAPPENED. THIS WAS DISCOVERED DURING A WRIST SCOPE PROCEDURE ON (B)(6) /2024. ADDITIONAL INFORMATION RECEIVED ON 10/3/2024: THE DISSECTOR DID NOT PRODUCE SMOKE. THE DISSECTOR SLIGHTLY BURNED THE PATIENT'S TISSUE. NO OPERATING ROOM STAFF WAS HARMED BY THE OVERHEATED DISSECTOR. THE DISSECTOR PRODUCED METAL SHAVINGS, AND THEY WERE CLEANED OUT WITH THE AR-7300RBE BURR USED TO COMPLETE THE CASE. A DUALWAVE OUTFLOW TUBING, A PUMP, AND VACUUM/WALL SUCTION WERE NOT USED DURING THE CASE. THERE WAS NO UNINTERRUPTED FLOW OF IRRIGATION THROUGH THE DEVICE WHILE IN USE. THE AR-7300DS DISSECTOR WAS USED IN OSCILLATION AND FORWARD DIRECTION. THE CASE WAS DELAYED TEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Burn(s)

  MAUDE report 20472854 ↗
• MalfunctionOct 17, 2024Overheating of Device; Overheating of Device

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-7300DS DISSECTOR BECAME EXTREMELY HOT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 10/3/2024: THE DISSECTOR DID NOT PRODUCE SMOKE. NO OPERATING ROOM STAFF OR PATIENT WAS HARMED BY THE OVERHEATED DISSECTOR. THE CASE WAS COMPLETED USING A NEW AR-7300DS WITH THE SETTINGS TURNED DOWN TO 2000. A DUALWAVE OUTFLOW TUBING, A PUMP, AND VACUUM/WALL SUCTION WERE NOT USED DURING THE CASE. THERE WAS NO UNINTERRUPTED FLOW OF IRRIGATION THROUGH THE DEVICE WHILE IN USE. THE AR-7300DS DISSECTOR WAS USED IN OSCILLATION AND FORWARD DIRECTION. THE CASE WAS DELAYED FIFTEEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20469772 ↗
• MalfunctionSep 12, 2024Material Fragmentation; Material Fragmentation

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-7300DS DISSECTOR, SJ 3.0MM X 7CM WAS REPORTED TO HAVE SOME BLACK FLAKES COMING OFF IT. THIS WAS DETECTED DURING ANKLE ARTHROSCOPY PROCEDURE ON (B)(6) 2024. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199942 ↗
• MalfunctionSep 11, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A SURGERY THE USE OF THE SHAVERBLADE RESULTED IN METAL DEBRIS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE DW 06-SEP-2024: FURTHER INFORMATION WAS PROVIDED THAT HE CASE TOOK PLACE ON AUGUST 20TH WITH AN AR-7300DS - LOT 15205016. THIS EVENT OCCURRED DURING A WRIST ARTHROSCOPY. THE FRAGMENTS WERE FOUND INSIDE THE PATIENT'S JOINT AND COULD BE PARTIALLY REMOVED. THE SURGERY WAS COMPLETED SUCCESSFUL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20192949 ↗
• MalfunctionSep 5, 2024Overheating of Device; Overheating of Device

  ON 08/08/2024, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA SEMS (B)(4) THAT AN AR-7300DS DISSECTOR HAD AN ISSUE DURING TESTING. THE SURGEON PERFORMED THE OSCILLATION BACK AND FORTH WITHOUT ANY PROBLEM. IT WAS THEN PASSED TO THE ASSISTANT, WHO MADE IT WORK AGAIN. THE TIP THEN TURNED BRIGHT RED AND HAD SPARKS, CAUSING THE DEVICE TO BE BURNED AND INOPERATIVE (SEE PHOTO ATTACHED). THIS WAS DISCOVERED BEFORE USE DURING A HAND ARTHROSCOPY PROCEDURE ON (B)(6) 2024, WITH NO REPORTED HARM TO THE PATIENT, SURGEON, OR THE FACILITY'S STAFF. ADDITIONAL INFORMATION WAS RECEIVED ON 09/02/2024: THE AR-7300DS DISSECTOR WAS CONNECTED TO THE SHAVER HANDPIECE AND THE SHAVER CONSOLE DURING THE EVENT. NO HARM WAS CONFIRMED TO THE PATIENT, SURGEON, OR THE FACILITY'S STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20144501 ↗
• MalfunctionAug 22, 2024Material Fragmentation; Material Fragmentation

  ON 08/05/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-(B)(4) THAT AN AR-7300DS. DISSECTOR BEGAN TO PRODUCE METAL DEBRIS. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH A SUBSTITUTE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041516 ↗
• MalfunctionJun 17, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A RESECTION SURGERY METAL ABRASION OCCURRED WITH THE DEVICE. ALL FRAGMENTS WERE RETRIEVED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19549088 ↗
• MalfunctionJun 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-7300DS DISSECTOR HAD ISSUES DURING USE. THE FIRST DISSECTOR, THE BLADE WOULD NOT SPIN. THE SECOND DISSECTOR TURNED RED AT THE TIP AND STARTED SMOKING. IT SEEMS AS IF THE INNER AND OUTER BLADES WERE FUSED TOGETHER. ADDITIONAL INFORMATION RECEIVED ON 12/27/2022: THIS WAS DISCOVERED DURING AN ANKLE SCOPE PROCEDURE ON (B)(6) 2022. NOTHING BROKE INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488990 ↗
• MalfunctionMay 22, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED DURING A KNEE PROCEDURE, AS THE SURGEON INSERTED THE AR-8330H SHAVER HAND PIECE, WITH A 3.0 SJ DISSECTOR THE DEVICE STARTED MAKING A HIGH PITCHED NOISE. THE SURGEON PULLED THE SHAVER FROM THE JOINT AND CYCLED IT ON/ OFF. THE SURGEON RE-INSERTED THE AR-8330H INTO THE JOINT THE SAME NOISE WAS HEARD. WHEN THE SURGEON REMOVED THE HANDPIECE THE TIP WAS GLOWING RED FROM FRICTION. THE SALE REP OPENED ANOTHER SHAVER (SAME LOT) AND IT HAPPENED AGAIN. ADDITIONAL INFORMATION 8/2/2021: IT WAS REPORTED DURING A KNEE PROCEDURE, AS THE SURGEON INSERTED THE AR-8330H SHAVER HAND PIECE, WITH A 3.0 SJ DISSECTOR THE DEVICE STARTED MAKING A HIGH PITCHED NOISE. THE SURGEON PULLED THE SHAVER FROM THE JOINT AND CYCLED IT ON/ OFF. THE SURGEON RE-INSERTED THE AR-8330H INTO THE JOINT THE SAME NOISE WAS HEARD. WHEN THE SURGEON REMOVED THE HANDPIECE THE TIP WAS GLOWING RED FROM FRICTION. THE SALE REP OPENED ANOTHER SHAVER (SAME LOT) AND IT HAPPENED AGAIN. THE SALES REP CONFIRMED, NO DEBRIS, FROM THE SHAVER THE TIP JUST BEGAN TO GLOW RED FROM HEAT. THE CASE WAS COMPLETED BY OPENING A NEW AR-8330H SHAVER AND NEW DISSECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369287 ↗
• MalfunctionMay 14, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE INNER SHAVER BLADE SHAFT BROKE OFF AND LODGED IN THE WINDOW OF THE OUTER SHAVER BLADE. STAFF WERE ABLE TO SAFELY REMOVE THE SHAVER BLADE FROM THE KNEE WITHOUT LOSING THE BROKEN TIP OF THE INNER SHAVER BLADE. ONCE THE BLADE WAS REMOVED FROM THE JOINT THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE CASE WITHOUT ANY COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310712 ↗
• MalfunctionMar 8, 2024Material Fragmentation; Material Fragmentation

  ON 02/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7300DS DISSECTOR LEFT METAL SHAVINGS. DOCTORS WERE ABLE TO GET MOST OF THEM OUT. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869182 ↗
• MalfunctionMar 6, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY THE SHAVER BLADES PRODUCES METAL DEBRIS. THE METAL PARTICLES COULD BE FLUSHED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846172 ↗
• MalfunctionMar 4, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY THE SHAVER BLADES PRODUCES METAL DEBRIS. THE METAL PARTICLES COULD BE FLUSHED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827957 ↗
• MalfunctionFeb 5, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A SURGERY THE USE OF THE SHAVER BLADE RESULTED IN METAL DEBRIS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE DW 31-JAN-2024: FURTHER INFORMATION WAS PROVIDED THAT METAL DEBRIS REMAINED INSIDE THE PATIENT'S JOINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18645224 ↗
• MalfunctionJan 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A HAND JOINT ARTHROSCOPY THE USE OF THE SHAVERBLADE RESULTED IN METAL DEPOSITS IN THE PATIENT'S JOINT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 18582115 ↗