Arthrex® AR-7300SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00888867041974), received between May 20, 2020 and Mar 17, 2026 — classified as 2 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (23 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A SURGICAL RESECTION, THE DEVICE CAUSED METAL DEBRIS, SOME OF WHICH REMAINED IN THE PATIENT. 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: Foreign Body In Patient

  MAUDE report 24616577 ↗
• MalfunctionMar 17, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A SURGICAL RESECTION, THE DEVICE CAUSED METAL DEBRIS, SOME OF WHICH REMAINED IN THE PATIENT. 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: Foreign Body In Patient

  MAUDE report 24616333 ↗
• MalfunctionMar 5, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC HAND SURGERY THE DEVICE PRODUCED DEBRIS. THE DEBRIS WAS RETRIEVED OUT OF THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519768 ↗
• MalfunctionJan 12, 2026Material Fragmentation

  ON 22ND DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR (B)(4) UNIT OF AR-7300SR, SABRE, SJ, 3.0 MM X 7 CM, METAL PARTICLES WERE GENERATED WHEN IN USED. THIS WAS DETECTED DURING A WRIST RECON ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035473 ↗
• MalfunctionDec 3, 2025Material Fragmentation; Material Fragmentation

  ON 11/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7300SR SABRE IS LEAVING METAL SHAVINGS BEHIND IN THE JOINT. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704915 ↗
• MalfunctionSep 8, 2025Smoking; Smoking

  ON 08/19/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7300SR SABRE HAD THE TIP GET REALLY HOT AND BEGIN TO SMOKE PRIOR TO A CASE. THIS WAS DISCOVERED WITH NO CASE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999280 ↗
• MalfunctionAug 22, 2025Overheating of Device; Overheating of Device

  ON (B)(6) 2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4). THE SURGEON WAS USING THE ARTHROSCOPY SHAVER 3.0MM SABRE AR-7300SR OUTSIDE OF SCOPING TO DEBRIDE THE CARTILAGE WHEN THE SINGLE-USE SHAVER BLADE SPARKED AND BURNED THE PATIENT¿S BONE. ADDITIONAL INFORMATION WAS RECEIVED ON 14-AUG-2025: THE REPORTER CLARIFIED THAT THERE WAS A SMALL ISOLATED BURN TO THE PATIENT¿S BONE WHICH WAS REMOVED IMMEDIATELY AFTER THE INCIDENT OCCURRED. A RONGEUR WAS USED TO COMPLETE THAT PART OF THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 19-AUG-2025: THE REPORTER STATED THAT THE INCIDENT OCCURRED DUE TO THE LACK OF IRRIGATION WHEN THE SURGEON WAS DEBRIDING THE CARTILAGE.

  Patient problems: Burn(s)

  MAUDE report 22872308 ↗
• MalfunctionAug 14, 2025Overheating of Device; Overheating of Device

  ON 07/29/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-7300SR SABRE WHEN THE DEVICE WAS LOADED INTO THE HANDPIECE AND USED, IT MADE AN UNUSUAL NOISE, DID NOT WORK PROPERLY, AND THE TIP TURNED BLACK FROM OVERHEATING. ADEQUATE IRRIGATION WAS NOT USED WHEN THE DEVICE WAS RUNNING. THERE WAS NO BURNING OR SMOKING SMELL. THE DEVICE BEGAN TO SMOKE BEFORE USE INSIDE THE PATIENT. THE DEVICE WAS DISCONTINUED AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS USING A PRODUCT OF THE SAME PART NUMBER AND LOT. THIS OCCURRED BEFORE USE IN A CASE, DURING TESTING OF THE DEVICE, WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803771 ↗
• MalfunctionJul 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A HAND ARTHROSCOPY THE DEVICE DAMAGED ITSELF WHEN ACTIVATED RESULTING IN METAL SHAVINGS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385952 ↗
• MalfunctionDec 6, 2024Material Fragmentation; Material Fragmentation

  ON 11/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06710476 THAT AN AR-7300SR SABRE CAUSED METAL FRAGMENTS. THIS OCCURRED DURING USE IN A CASE. THE CASE WAS COMPLETED THE REPAIR USING AN OPEN TECHNIQUE IN ORDER TO FLUSH OUT METAL REMNANTS. SLIGHT DELAY TO CASE, EXTRA IRRIGATION USED TO FLUSH OUT THE METAL SHAVINGS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20868524 ↗
• 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-7300SR SABRE BEGAN TO PRODUCE METAL DEBRIS. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH A SUBSTITUTE PRODUCT. THE BLADE WAS USED INSIDE THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043047 ↗
• MalfunctionAug 6, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE JOINT WAS FILLED WITH DEBRIS. THE DEBRIS WAS THEN REMOVED WITH A NEW DEVICE WITH THE SAME PART NUMBER. 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 19917892 ↗
• MalfunctionMay 28, 2024Material Fragmentation; Material Fragmentation

  ON 04/29/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT FIVE (5) AR-7300SR SABRES ARE LEAVING DEBRIS IN THE FORM OF A METAL POWDER WHEN BEING USED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE CASE WAS COMPLETED USING A REPLACEMENT PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404579 ↗
• MalfunctionMay 28, 2024Material Fragmentation; Material Fragmentation

  ON 04/29/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06553471 THAT FOUR (4) AR-7300SR SABRES ARE LEAVING DEBRIS IN THE FORM OF A METAL POWDER WHEN BEING USED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE CASE WAS COMPLETED USING A REPLACEMENT PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404103 ↗
• MalfunctionApr 18, 2024Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION WAS RECEIVED ON 3/26/2024:THERE WAS NO CASE DELAY AND THE CASE COMPLETED AS NORMAL WITHOUT ADVERSE EFFECTS ON THE PATIENT. THERE WERE NO PHOTOS OR VIDEOS TAKEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19130230 ↗
• MalfunctionApr 5, 2024Excessive Heating; Excessive Heating

  ON 11/2/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-7300SR SABRE HEATS UP SO MUCH THAT IT GLOWS RED FROM THE HEAT. THIS WAS DISCOVERED DURING A PROCEDURE. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19052263 ↗
• 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 18846156 ↗
• 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 18828033 ↗
• 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 18827690 ↗
• MalfunctionJan 19, 2024Break; Break

  ON 1/3/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-7300SR SABRE INTERIOR ROTATING PIECE BROKE OFF INTO THE PATIENT. THE PIECE WAS RETRIEVED BY THE OR TEAM, AND AN X-RAY WAS DONE TO ENSURE THAT ALL PIECES WERE ACCOUNTED FOR. THIS WAS DISCOVERED DURING AN ANKLE ARTHROSCOPY PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18544570 ↗
• MalfunctionDec 8, 2023Material Fragmentation; Material Fragmentation

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06400946 THAT AN AR-7300SR SABRE PRODUCED METAL SHAVINGS. THIS OCCURRED DURING AN ANKLE ARTHROSCOPY ON (B)(6) 2023 WHERE ANOTHER SHAVER WAS USED TO COMPLETE THE CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18292442 ↗
• MalfunctionOct 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY THE SHAVER PRODUCED METAL ABRASIONS. THE KNEE WAS IRRIGATED TO ENSURE THAT NO METAL DEBRIS REMAINED IN THE PATIENT. 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 18004016 ↗
• MalfunctionSep 29, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY USING THE AUTOCARD TECHNIQUE METAL DEBRIS WAS PRODUCED ON THE CARTILAGE. 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. UPDATE (B)(6) 2023 NROE: THE METAL DEBRIS COULD BE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17845245 ↗
• InjuryMay 30, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN AUTOCART SURGERY AT THE ANKLE METAL DEBRIS WAS PRODUCED BY THE DEVICE. 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. (B)(6)2023 UPDATE DW. FURTHER INFORMATION WERE PROVIDED THAT IT APPEARS THAT NOT ALL FRAGMENTS COULD BE RETRIEVED OUT OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17017774 ↗
• MalfunctionJan 9, 2023Material Fragmentation; Material Fragmentation; Output Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-7300SR SABRE PRODUCED DEBRIDEMENT OF TISSUE IN THE PATIENT WHILE BEING USED. SHAVINGS WERE LEFT IN THE JOINT. THIS WAS DISCOVERED DURING A WRIST SCOPE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16120517 ↗