Arthrex® AR-9216-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867192638), received between Aug 4, 2023 and Aug 12, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A SHOULDER PROSTHESIS SURGERY ABRASION OCCURRED, SOME OF WHICH REMAINED STUCK TO THE PATIENT AND THE INSTRUMENT. NOTHING REMAINED IN THE PATIENT; IT WAS RINSED OUT. 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 22783245 ↗
• MalfunctionAug 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A SHOULDER PROSTHESIS SURGERY ABRASION OCCURRED, SOME OF WHICH REMAINED STUCK TO THE PATIENT AND THE INSTRUMENT. NOTHING REMAINED IN THE PATIENT; IT WAS RINSED OUT. 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 22783243 ↗
• MalfunctionDec 26, 2024Break; Break

  ON (B)(6) 2024 , A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9510-01 ARTHREX UNIVERS REVERS¿ VERSION ROD AND AN AR-9216-4 GLENOID REAMER/DRILL GLOVE PROTECTOR BROKE DURING USE. THE CASE WAS COMPLETED SUCCESSFULLY. NO PIECES BROKE OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2024 , WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021296 ↗
• MalfunctionNov 13, 2024Defective Device; Naturally Worn; Defective Device; Naturally Worn

  ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9216-4 GLENOID REAMER/DRILL GLOVE PROTECTOR BLUE SLEEVE WAS WORN DOWN ENOUGH OVER TIME THAT IT NO LONGER STAYS ON THE DRIVESHAFT AND JUST SLIDES OFF. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED. THE SECOND BLUE SLEEVE IN THE TRAY WAS USED, AND THE CASE WAS COMPLETELY WITHOUT INCIDENT. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678199 ↗
• MalfunctionJun 19, 2024Material Deformation; Material Deformation

  ON 03/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9216-4 DRILL GLOVE PROTECTOR COLLAPSED DURING DRILLING. THIS WAS DISCOVERED DURING A PROCEDURE ON 3/23/2022. ADDITIONAL INFORMATION RECEIVED 3/28/2022: THIS WAS DISCOVERED DURING AN ECLIPSE TSA. THE DRILL GLOVE PROTECTOR, DURING DRILLING, WAS PUSHED IN AND WARPED ON ONE SIDE. NOTHING BROKE INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570127 ↗
• MalfunctionApr 29, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A REVERSE SHOULDER SURGERY WHEN USING THE DEVICES AR-9216-4 (LOT: 022220) AND AR-9617 (LOT: 022225) IN COMBINATION DEBRIS WAS PRODUCED FROM THE AR-9216-4. 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 AVOE 08-APR-2024: IT WAS CONFIRMED THAT THE ERROR OCCURRED WHILE WORKING IN THE PATIENT, BUT NO DEBRIS FELL INTO THE PATIENT AND THEREFORE NOTHING HAD TO BE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203705 ↗
• MalfunctionApr 29, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A REVERSE SHOULDER SURGERY WHEN USING THE DEVICES AR-9216-4 (LOT: 022220) AND AR-9617 (LOT: 022225) IN COMBINATION DEBRIS WAS PRODUCED FROM THE AR-9216-4. 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 AVOE 08-APR-2024. IT WAS CONFIRMED THAT THE ERROR OCCURRED WHILE WORKING IN THE PATIENT, BUT NO DEBRIS FELL INTO THE PATIENT AND THEREFORE NOTHING HAD TO BE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203638 ↗
• MalfunctionNov 1, 2023Material Fragmentation; Material Fragmentation

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-5410-01 VIP GLENOID REAMER, PILOT SHARP EDGE ON THE BUTT OF THE CALIBRATED PORTION CAUSED DAMAGE TO THE AR-9216-4 DRILL GLOVE PROTECTOR BY LEAVING BITS OF PLASTIC SHAVINGS IN THE PATIENT'S SHOULDER WOUND. THE CASE WAS COMPLETED SUCCESSFULLY BY RETRIEVING THE PIECES LEFT IN THE PATIENT. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2023. PRODUCT CHECKLIST WAS UPDATED AND ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THERE WAS A UNSPECIFIED AMOUNT OF DELAY WHEN REMOVING ALL THE FRAGMENTS FROM THE PATIENT AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ADVERSE EFFECTS FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18047419 ↗
• MalfunctionAug 4, 2023Material Fragmentation; Material Fragmentation

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AR-9617 DRIVE SHAFT AR-9216-4 REAMER/DRILL GLOVE PROTECTOR PRODUCES METAL SHAVING WHEN CONNECTED AND IN USE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 7/13/2023: THIS WAS DISCOVERED DURING AN ECLIPSE PRIMARY TOTAL SHOULDER PROCEDURE ON (B)(6) 2023. THE DEBRIS WAS PRODUCED ON THE BACK TABLE AND NOT WHILE REAMING INSIDE OF THE PATIENT. DIFFERENT SLEEVES AND DRIVERS WERE TIRED MULTIPLE TIMES. BUT EACH BLUE SLEEVE CONTINUED TO DROP SHAVINGS ON THE BACK TABLE. THE SLEEVES AND DRIVERS WERE SWITCHED OUT TO A DIFFERENT SET, AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THE EXACT PART NUMBERS FOR THE NEW SET ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17458157 ↗